Unified eClinical Solution

  • You’ll work alongside a knowledgeable, creative and energetic group of colleagues focused on providing exceptional service and best-in-class solutions to our life sciences clients.
  • You’ll develop close relationships with our clients as part of a team that understands how to meet, and exceed, each of our clients’ specific needs.
  • You’ll be a part of each study’s success and your focus, consistent effort and good ideas will help us to continue to improve everything we do so that we keep “wowing” our clients.

Are you a good fit for us? Are we a fit for you?

We want to meet you if you’re smart, hard working, ambitious, and passionate about working in an entrepreneurial environment. Axiom is a great place for you if you’re eager to use all of your skills, interested in growing your responsibilities, and love to have fun while you do great work.

If you’re interested in working with us, but don’t see a role currently listed, please feel free to send us your resume, along with a short summary of your skills and why you’d like to work with us to careers@axiom.cc and we’ll be in touch.

Current opportunities
are posted below.

To apply please submit your resume, along with a short summary of your skills and why you’re the best fit for this role, below. We look forward to hearing from you.

SENIOR DATA MANAGER – (Full Time)

Toronto, Ontario

ABOUT THE ROLE

This is a full-time Senior Data Manager position.

Candidates should have 7-10 years’ prior experience working in Data Management at a CRO/ Biotech /Pharmaceuticals. Candidates who do not meet this criterion will not be considered for this role.

The Senior Data Manager is responsible for oversight on data management activities for one or more clinical trials, manage a team of Data Managers, working closely with various members of Axiom departments.

KEY RESPONSIBILITIES

  • Management of a team
  • Oversight of all Data Management activities pertaining to a study from study start-up t close-out, ensuring data integrity is maintained
  • Management of assigned projects resources on an ongoing basis
  • Responsible for ensuring all key Data Management deliverables are met across applicable project groups
  • Oversight of Client Communications – both written and verbal
  • Coaching and development of Data Management team members
  • Close, ongoing collaboration with members of project team to ensure project runs smoothly and efficiently and that overall strategic objectives are realized
  • Contribute to innovative solutions to enhance Axiom Data Management processes
  • Development and Implementation of Axiom Real Time Metrics SOPs

REQUIRED EXPERIENCE & EDUCATION

  • 7-10 years’ experience in a professional service environment
  • 5+ years’ experience in CRO/ Biotech/ Pharmaceuticals
  • Oncology experience is an asset
  • Working knowledge of clinical/medical/biology terminology.
  • Clinical Research Postgraduate Certificate
  • or recognized equivalent in Health or Science related field
  • Clinical professional degree e.g. CCRP accreditation
  • Familiarity with CDISC standards and SDTM datasets
  • Knowledge of ICH-GCP
  • Experience with EDC systems (data entry and/or configuration)
  • At least 1 year in a management / team leader role
  • Proficiency in Microsoft Word, Excel, PowerPoint, Project and Outlook
  • Proven to take initiative
  • Excellent Leadership experience
  • Ability to mentor junior staff
  • Enthusiastic, smart, resourceful, analytical
  • Well-developed written and communication skills
  • Perceptive listening skills
  • Strong attention to detail
  • Time management skills
  • Ability to work independently within a team environment
  • Adept at multi-tasking
  • Basic understanding of web-based technologies and browsers

APPLY FOR THIS POSITION

All interested applicants are requested to submit a resume and cover letter. We thank all applicants in advance for their interest but only those selected for interview process will be contacted. No phone calls or third-party recruiters please.

Axiom is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with a disability.

ABOUT THE COMPANY

Axiom Real-Time Metrics Inc. is a leading technology company in the clinical trial space. We work with small to medium biotech, pharma and CROS to provide efficient technology platforms to commence and enhance clinical trials/clinical studies.

We are a growing diverse team developing and supporting an innovative system where you will make significant contributions to challenging projects using leading edge technology in a collaborative environment.

Axiom offers flexible hours. We believe in allowing our creativity to flourish working in a laid-back professional but casual environment. We are jean friendly; every day and we keep an employee lounge stocked with a variety of snacks and coffee.

The Company is very team oriented and we believe in celebrating our milestones and colleagues. We often have Company events, luncheons and ice cream days during the summer. We organize community service events and team building outings to promote and celebrate collaboration. We work hard but smart and have a passion for leading edge technology with great customer service.

Sr. CLINICAL SUPPLY MANAGER – (Full Time)

Toronto, Ontario

The Sr. Clinical Supply Manager leads the start-up, ongoing management and closeout of inventory activities for clinical trials and/or registry projects, by working closely with members of RTSM (Randomization & Trial Supply Management), Clinical Operations and external Manufacturing and Depot vendors.

KEY RESPONSIBILITIES

  • Provide a support or lead role in depot contracting, review / development of labels, forecasting and ordering supplies
  • Manage depot and site inventory proactively with respect to expiration management and development of depot threshold settings / site resupply strategies
  • Liaise between clinical and manufacturing to coordinate clinical supply activities across multiple programs (at the study level and or program level)
  • Develop key documents (Supply Plans, Pharmacy Manuals, Accountability Trackers)

REQUIRED EDUCATION & EXPERIENCE

  • 6-10 years of experience in Clinical Supply Chain;
  • SCM, APICS or PMP Certification is an asset;
  • Experience and emphasis in ERP / IRT System configuration;
  • Knowledge of cGXP (GMP, GCP, GDP etc.) and quality systems;
  • Ability to multitask and prioritize in a fast-paced environment;
  • Ability to communicate in English at a business level, written and verbal;
  • Excellent organizational, time management and interpersonal skills;
  • Team player with strong attention to detail and excellent problem-solving skills;
  • Proven adaptability in dynamic, fast-paced work environments;
  • Tech savvy with advanced knowledge of Microsoft Office and the ability to quickly learn the Axiom IRT modules within our proprietary eClinical software

ABOUT THE COMPANY

  • Axiom Real-Time Metrics Inc. is a leading technology company in the clinical trial space. We work with small to medium biotech, pharma and CROs to provide efficient technology platforms to commence and enhance clinical trials/clinical studies.
  • We are a growing diverse team developing and supporting an innovative system where you will make significant contributions to challenging projects using leading edge technology in a collaborative environment.
  • Axiom offers flexible hours. We believe in allowing our creativity to flourish working in a laid-back professional but casual environment. We are jean friendly; every day and we keep an employee lounge stocked with a variety of snacks and coffee.
  • The Company is very team oriented and we believe in celebrating our milestones and colleagues. We often have Company events, luncheons and ice cream days during the summer.
  • We organize community service events and team building outings to promote and celebrate collaboration. We work hard but smart and have a passion for leading edge technology with great customer service.

APPLY FOR THIS POSITION

All interested applicants are requested to submit a resume and cover letter. We thank all applicants in advance for their interest but only those selected for interview process will be contacted. No phone calls or third-party recruiters please.

Axiom is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with a disability.

PROJECT MANAGER – CLINICAL OPERATIONS

Toronto, Ontario

ABOUT THE ROLE

This is a full-time Project Manager position.

Candidates should have 3+ years’ prior experience working in Project Management at a CRO/ Biotech /Pharmaceuticals. Candidates who do not meet this criterion will not be considered for this role.

The Project Manager is responsible for direct, daily management and oversight of multiple Axiom Fusion Projects, working closely with other members of Axiom departments.

KEY RESPONSIBILITIES

  • Oversight of all Project Management activities pertaining to a study; Study Start Up and Close-Out activities and documentation
  • Management of assigned projects resources on an ongoing basis
  • Responsible for ensuring all key client deliverables are met across applicable functional groups
  • Oversight of Client Communications – both written and verbal
  • eCRF and Study Module Management – configuration and validation
  • Financial Management of projects; ensuring Scope of Work remains on track
  • Coaching and development of Project Management Team members
  • Implementation of Axiom Real Time Metrics SOPs
  • Contribute to innovative solutions to enhance Axiom Project Management processes

REQUIRED EDUCATION & EXPERIENCE

  • 3+ years’ prior experience working in Project Management at a CRO/ Biotech /Pharmaceuticals
  • or recognized equivalent in Health or Science related field
  • Experience in pharmaceutical or CRO industry
  • Clinical Research Postgraduate Certificate
  • Clinical professional degree e.g. CCRP accreditation
  • Knowledge of ICH-GCP
  • Experience with EDC systems (data entry and/or configuration)
  • At least 1 year in a management / team leader role
  • Proven leadership / Project Management skills
  • Working knowledge of clinical / medical / biology
  • Proficiency in Excel, Microsoft Word, PowerPoint, Project and Outlook
  • Well-developed written and communication skills
  • Ability to collaborate effectively with others
  • Enthusiastic, smart, resourceful, analytical
  • Time management skills
  • Strong attention to detail
  • Adept at multi-tasking
  • Perceptive listening skills
  • Understanding of web-based technologies and browsers
  • Proven to take initiative

APPLY FOR THIS POSITION

All interested applicants are requested to submit a resume and cover letter. We thank all applicants in advance for their interest but only those selected for interview process will be contacted. No phone calls or third-party recruiters please.

Axiom is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with a disability.

ABOUT THE COMPANY

Axiom Real-Time Metrics Inc. is a leading technology company in the clinical trial space. We work with small to medium biotech, pharma and CROS to provide efficient technology platforms to commence and enhance clinical trials/clinical studies.

We are a growing diverse team developing and supporting an innovative system where you will make significant contributions to challenging projects using leading edge technology in a collaborative environment.

Axiom offers flexible hours. We believe in allowing our creativity to flourish working in a laid-back professional but casual environment. We are jean friendly; every day and we keep an employee lounge stocked with a variety of snacks and coffee.

The Company is very team oriented and we believe in celebrating our milestones and colleagues. We often have Company events, luncheons and ice cream days during the summer. We organize community service events and team building outings to promote and celebrate collaboration. We work hard but smart and have a passion for leading edge technology with great customer service.

PRODUCT COMMUNICATIONS SPECIALIST – (Full Time)

Toronto, Ontario

ABOUT THE ROLE

The Product Communications Specialist will work on external and internal communications related to the Company’s clinical trial technology Products and Product Features. Some of these communications will include but is not limited to writing, designing and disseminating content for newsletters, email communications, social media and trade show literature/content.

The ideal candidate shall already have strong familiarity with B2B communications, strong proficiency for technology and prior experience with client and internal communications with past experience working in the healthcare or technology sectors.

Candidates must have 3+ years of experience in Communications in North America in Technology, Pharma or Healthcare Industries.

Candidates who do not meet this criterion will not be considered for this role.
KEY RESPONSIBILITIES

  • Design, gather, write, edit, and proof content for email and web communication initiatives
  • Develop, execute, and manage Product Communications campaigns
  • Collaborate between internal colleagues and external mediums for content development
  • Design and develop Content Marketing Strategies
  • Oversee / Management of communications projects including milestone tracking and reporting

REQUIRED EDUCATION & EXPERIENCE

  • 3+ years of experience in Communications in Canada/US in Technology, Pharma or Healthcare Industries.
  • Should have a University Degree (i.e. BA, BCom, BBA, etc.) or a College Equivalent
  • Exceptional verbal and written communication skills
  • Well-developed time-management and organizational skills, with an ability to use judgement in task prioritization
  • Excellent attention to detail
  • Proficient in Microsoft Word, Excel, Power Point, Outlook, Adobe InDesign, Adobe Photoshop
  • Good understanding of digital technologies and marketing techniques and how they can be leveraged
  • Smart, driven, solutions-oriented, with a knack for problem solving and a habit of taking initiative.
  • Experience in the following are highly desired:
  • Technology, Pharma or Healthcare Industries
  • Content Marketing/Email Marketing / Digital Marketing / Digital Messaging / Graphic Design

ABOUT THE COMPANY

  • Axiom Real-Time Metrics Inc. is a leading technology company in the clinical trial space. We work with small to medium biotech, pharma and CROs to provide efficient technology platforms to commence and enhance clinical trials/clinical studies.
  • We are a growing diverse team developing and supporting an innovative system where you will make significant contributions to challenging projects using leading edge technology in a collaborative environment.
  • Axiom offers flexible hours. We believe in allowing our creativity to flourish working in a laid-back professional but casual environment. We are jean friendly; every day and we keep an employee lounge stocked with a variety of snacks and coffee.
  • The Company is very team oriented and we believe in celebrating our milestones and colleagues. We often have Company events, luncheons and ice cream days during the summer. We organize community service events and team building outings to promote and celebrate collaboration. We work hard but smart and have a passion for leading edge technology with great customer service.

APPLY FOR THIS POSITION

All interested applicants are requested to submit a resume and cover letter. We thank all applicants in advance for their interest but only those selected for interview process will be contacted. No phone calls or third-party recruiters please.

Axiom is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with a disability.

Bio-statistician – (Full Time)

Toronto, Ontario

ABOUT THE COMPANY

Axiom Real-Time Metrics Inc. is a leading technology company in the clinical trial space. We work with small to medium biotech, pharma and CROS to provide efficient technology platforms to commence and enhance clinical trials/clinical studies.

We are a growing diverse team developing and supporting an innovative system where you will make significant contributions to challenging projects using leading edge technology in a collaborative environment.

Axiom offers flexible hours. We believe in allowing our creativity to flourish working in a laid-back professional but casual environment. We are jean friendly; every day and we keep an employee lounge stocked with a variety of snacks and coffee.

The Company is very team oriented and we believe in celebrating our milestones and colleagues. We often have Company events, luncheons and ice cream days during the summer. We organize community service events and team building outings to promote and celebrate collaboration. We work hard but smart and have a passion for leading edge technology with great customer service.

JOB FUNCTION OVERVIEW

This full-time position is responsible for various aspects of statistical input and review of clinical studies (including but not limited to designing, analyzing and implementation) and review of statistical deliverables and data management deliverables.

KEY RESPONSIBILITIES

Key responsibilities and prior experience include familiarity with the following platforms and/or programs:

  • Configuring/validating SDTM and ADaM datasets
  • SAS programming experience
  • Contribute and Perform clinical study protocols and statistical documents
  • Write and/or review statistical sections of study reports
  • Analysis of statistical data
  • Thorough knowledge of FDA requirements

Required Education & Prior Job Experience.

Bio-statistics Advanced Degree -Master’s and/or doctorate degree in bio-statistics is required or related field such as mathematics or biology.

  • Must have at least 5 years prior work experience as a Bio-statistician.
  • Prior work experience of at least 3 years within clinical research sector is preferred.

Benefits.

  • Company paid medical, dental, vision, Healthcare Spending Account.

SENIOR PROJECT MANAGER  – (Full Time)

Toronto, Ontario

ABOUT THE ROLE

This is a full-time Senior Project Manager position.

Candidates should have 5-7 years’ prior experience working in Project Management at a CRO/ Biotech /Pharmaceuticals. Candidates who do not meet this criterion will not be considered for this role.

The Senior Project Manager is responsible for direct, daily management and oversight of multiple Axiom Fusion Projects, working closely with other members of Axiom departments.

KEY RESPONSIBILITIES

  • Oversight of all Project Management activities pertaining to a study; Study Start Up and Close-Out activities and documentation
  • Management of assigned projects resources on an ongoing basis
  • Responsible for ensuring all key client deliverables are met across applicable functional groups
  • Oversight of Client Communications – both written and verbal
  • eCRF and Study Module Management – configuration and validation
  • Financial Management of projects; ensuring Scope of Work remains on track
  • Coaching and development of Project Management Team members
  • Implementation of Axiom Real Time Metrics SOPs
  • Contribute to innovative solutions to enhance Axiom Project Management processes

REQUIRED EDUCATION & EXPERIENCE

  • 7-10 years’ experience in a professional service environment
  • 5+ years’ experience in CRO/ Biotech/ Pharmaceuticals
  • Clinical Research Postgraduate Certificate
  • or recognized equivalent in Health or Science related field
  • Clinical professional degree e.g. CCRP accreditation
  • Knowledge of ICH-GCP
  • Experience with EDC systems (data entry and/or configuration)
  • At least 1 year in a management / team leader role
  • Proven leadership / Project Management skills
  • Working knowledge of clinical / medical / biology
  • Proficiency in Excel, Microsoft Word, PowerPoint, Project and Outlook
  • Well-developed written and communication skills
  • Ability to collaborate effectively with others
  • Enthusiastic, smart, resourceful, analytical
  • Time management skills
  • Strong attention to detail
  • Adept at multi-tasking
  • Perceptive listening skills
  • Understanding of web-based technologies and browsers
  • Proven to take initiative

APPLY FOR THIS POSITION

All interested applicants are requested to submit a resume and cover letter. We thank all applicants in advance for their interest but only those selected for interview process will be contacted.  No phone calls or third-party recruiters please.

Axiom is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with a disability.

ABOUT THE COMPANY

Axiom Real-Time Metrics Inc. is a leading technology company in the clinical trial space. We work with small to medium biotech, pharma and CROS to provide efficient technology platforms to commence and enhance clinical trials/clinical studies.

We are a growing diverse team developing and supporting an innovative system where you will make significant contributions to challenging projects using leading edge technology in a collaborative environment.

Axiom offers flexible hours. We believe in allowing our creativity to flourish working in a laid-back professional but casual environment. We are jean friendly; every day and we keep an employee lounge stocked with a variety of snacks and coffee.

The Company is very team oriented and we believe in celebrating our milestones and colleagues. We often have Company events, luncheons and ice cream days during the summer. We organize community service events and team building outings to promote and celebrate collaboration. We work hard but smart and have a passion for leading edge technology with great customer service.

SENIOR QUALITY ASSURANCE ASSOCIATE

*Must have prior experience with ISO 9001 & GCP

ABOUT THE ROLE

The Senior Quality Assurance Associate is involved with the direct and daily administration of the Quality Management System, working closely with the Director, Quality Assurance and members of the Project Management, Data Management, Software Engineering, Product Management, and Customer Care teams.

This is a full-time opportunity reporting to the Quality Assurance Manager.

Candidates must have 5+ years’ Quality Assurance experience in GCP / GMP role working at a CRO/ Biotech /Pharmaceuticals. Candidates who do not meet this criterion will not be considered for this role.

 

KEY RESPONSIBILITIES

  • Provide oversight of activities to ensure compliance with GxPs.
  • Prepares key quality documentation (deviations, change control, and CAPA documentation) that impact quality of products.
  • Review and approve GxP documentation including deployment records.
  • Liaise with internal groups to ensure detailed investigations and root cause analysis for non-compliance issues in a timely manner.
  • Aids in performing compliance audits in all departments and prepares results reports for Director, Quality Assurance. Ensures outstanding corrective actions from the audits to ensure timely corrective actions.
  • Demonstrates a primary commitment to product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Participate in the compilation of KPIs.
  • Oversee the compliance of the internal training process.
  • Investigates non-conformances to ensure recurrence is prevented.
  • Participates in special projects as required in other areas of Quality and Compliance as assigned by the Director, Quality Assurance
  • Perform other related duties as assigned.

REQUIRED EXPERIENCE & EDUCATION

  • 5+ years working experience in GxP role in either the pharmaceutical or clinical industry
  • Minimum 3+ years working experience in a QA Investigative Role
  • Working knowledge of clinical trial process
  • Thorough knowledge of GxP
  • Thorough knowledge of industry specific regulatory compliance and frameworks (EU, Health Canada, FDA, cFDA, etc.)
  • A good understanding of ISO:9001
  • Excellent oral, written communication, time management and organizational skills
  • Ability to work independently in a team environment
  • Proficient in Microsoft Word, excel, Power point, Project and Outlook
  • Strong attention to detail

APPLY FOR THIS POSITION

All interested applicants are requested to submit a resume and cover letter. We thank all applicants in advance for their interest but only those selected for interview process will be contacted. No phone calls or third-party recruiters please.

Axiom is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with a disability.

 

ABOUT THE COMPANY

Axiom Real-Time Metrics Inc. is a leading technology company in the clinical trial space. We work with small to medium biotech, pharma and CROS to provide efficient technology platforms to commence and enhance clinical trials/clinical studies.

We are a growing diverse team developing and supporting an innovative system where you will make significant contributions to challenging projects using leading edge technology in a collaborative environment.

Axiom offers flexible hours, the ability to choose work schedule allowing you to avoid the worst of Toronto’s rush-hour traffic. We believe in allowing our creativity to flourish working in a laid-back professional but casual environment. We are jean friendly; every day and we keep an employee lounge stocked with a variety of snacks and coffee.

The Company is very team oriented and we believe in celebrating our milestones and colleagues. We often have Company events, luncheons and ice cream days during the summer. We organize community service events and team building outings to promote and celebrate collaboration. We work hard but smart and have a passion for leading edge technology with great customer service.

 

RTSM/IWRS SPECIALIST

ABOUT THE ROLE

The RTSM/IWRS Specialist supports RTSM/IWRS Management in leading the creation, ongoing management and closeout of the Randomization and CTM Tracking Modules for clinical trials and/or registry projects, by working closely with other members of the Global Delivery and Customer Care teams.

KEY RESPONSIBILITIES

  • General Project Management
    • Project Planning / Timelines
    • Coordination and management of internal / client meetings
    • External Communication
  • Axiom Application Support
    • Module & Report Design and Configuration
    • Module & Report Validation/Testing
    • Development of Module related tools, including: Tips & Tools / User Guides
    • Issue Management
  • End-User Support
  • Randomization Activities
    • Randomization Module List Review, Loading & Validation
    • Randomization Monitoring – Live Randomization Validation, ongoing cohort / site activation, IWRS Scenario Management
    • Unblinding Management – Unblinding Requests, Code Break Module activities
    • Unblinded Data Exports – Creation of Unblinded DES and validation of Unblinded Data Exports
  • Inventory Activities
    • Inventory Loading & Activation
    • Inventory Monitoring – Raising initial / manual resupply requests, ongoing review and reconciliation

REQUIRED EDUCATION & EXPERIENCE

  • or recognized equivalent in Health or Science related field
  • 3 years of experience working with IWRS / IVRS / ERP/ RTSM/ IRT systems (randomization and / or inventory management)
  • Clinical Research Postgraduate Certificate
  • Knowledge of ICH-GCP
  • Experience with EDC systems (data entry and/or configuration)
  • Experience in healthcare / pharmaceutical industry
  • Proficient in MS Office Suite
  • 5 years of experience working with IWRS / IVRS / ERP systems (randomization and / or inventory management)
  • 5 – 8 years in a professional service environment
  • Basic understanding of web-based technologies and browsers
  • Passion for clinical research
  • Well-developed interpersonal, oral and written communication skills
  • Perceptive listening skills
  • Strong critical thinking skills and attention to detail
  • Effective time management and organizational skills
  • Adept at multi-tasking and prioritizing
  • Proven ability to work independently and within a team environment

 

ABOUT THE COMPANY

  • Axiom Real-Time Metrics Inc. is a leading technology company in the clinical trial space. We work with small to medium biotech, pharma and CROs to provide efficient technology platforms to commence and enhance clinical trials/clinical studies.
  • We are a growing diverse team developing and supporting an innovative system where you will make significant contributions to challenging projects using leading edge technology in a collaborative environment.
  • Axiom offers flexible hours. We believe in allowing our creativity to flourish working in a laid-back professional but casual environment. We are jean friendly; every day and we keep an employee lounge stocked with a variety of snacks and coffee.
  • The Company is very team oriented and we believe in celebrating our milestones and colleagues. We often have Company events, luncheons and ice cream days during the summer. We organize community service events and team building outings to promote and celebrate collaboration. We work hard but smart and have a passion for leading edge technology with great customer service.

 

APPLY FOR THIS POSITION

All interested applicants are requested to submit a resume and cover letter. We thank all applicants in advance for their interest but only those selected for interview process will be contacted. No phone calls or third-party recruiters please.

Axiom is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with a disability.

TRIAL MASTER FILE MANAGER

ABOUT THE ROLE

The TMF Manager is responsible to oversee the set-up, review, maintenance and archival of the trial master file (TMF) including analysis of key performance indicators related to clinical trial documentation and system administration of the electronic TMF (eTMF). The role is focused on TMF quality and provides strategic support across clinical development functions to achieve and maintain TMF inspection-readiness.

Candidates must have Four (4) years industry experience with at least two (2) years of experience working directly with clinical trial documentation in North America.

Candidates who do not meet this criterion will not be considered for this role.
KEY RESPONSIBILITIES

  • Serve as the primary point of contact for TMF processes, systems, and controls, including relevant guidance and training documentation.
  • Develop the project-specific TMF Plan and expected content index with input from the Project Manager and/or Sponsor and serve as the primary resource in maintaining the inspection-readiness of the TMF. Plans may include TMF transition and/or migration activities.
  • Provide tracking, analysis and reporting of key performance indicators related to clinical trial documentation, including contemporaneousness, accuracy, and completeness of TMFs against milestone-based projections, to proactively provide feedback to stakeholders regarding performance against expectations.
  • Verify the acceptability of submitted TMF documents as per applicable specifications, standard operating procedures, ICH/GCP guidelines and other regulatory requirements. Review the work of others who perform TMF quality control checks to ensure compliance with relevant parameters.
  • Perform or assign periodic TMF assessments for inspection-readiness in accordance with the TMF Plan, establishing and ensuring the enforcement of due dates for expected TMF content based on planned trial design and unanticipated events occurring during trial conduct. Review and track the outcomes of TMF reviews to demonstrate compliance with quality plans and to identify and address trends.
  • Serve as subject matter expert and system administrator for Fusion eTMF, Axiom Metrics’ electronic TMF (eTMF) application, including technical understanding of system configuration and security and related filing processes and conventions, and coordination of system training and user access.
  • Control eTMF system access and manage user accounts in accordance with applicable regulations, e.g.,21CFR11.
  • Facilitate/attend departmental and project team meetings.
  • Maintain advanced technical knowledge of industry standards and applicable regulatory requirements to ensure adequacy of the TMF system and continuous process improvement. Conduct trainings and educate TMF team and contributors about the tools, systems, and procedures for managing documentation.
  • Participate in internal or external audits, including facilitation of inspector access to TMFs as required.
  • Coordinate and oversee document management services as contracted, including deliverables and relevant metrics.
  • Additional Responsibilities
  • Perform other duties as requested by the Director, Clinical Management, QA, eClinical PM, Product Innovation or other departments as appropriate.

REQUIRED EDUCATION & EXPERIENCE

  • Four (4) years industry experience with at least two (2) years of experience working directly with clinical trial documentation.
  • Experience with Veeva Vault, Master Control, Motrium, Aris Global, or other widely industry used system is preferred.
  • An Associate’s or Bachelor’s Degree is preferred but not required.
  • On the job or professional training in regulatory document collection and electronic content management systems required.
  • Expertise in use and application of the TMF Reference Model file structure required.
  • The ideal candidate has excellent organizational and time management skills, and high level of attention to detail with proactive approach and follow through.
  • Must have ability to balance multiple projects simultaneously and possess strong computer acumen including advanced proficiency with Microsoft Office suite and familiarity with clinical trial applications including those used to manage and archive regulatory content.
  • Should demonstrate strong ability to manage within a matrixed organization, prioritizing multiple tasks in a timely, budget-conscious and quality­ driven manner.
  • Should possess knowledge of and demonstrate ability to apply pertinent applicable regulations and guidelines including GCPs.

ABOUT THE COMPANY

  • Axiom Real-Time Metrics Inc. is a leading technology company in the clinical trial space. We work with small to medium biotech, pharma and CROs to provide efficient technology platforms to commence and enhance clinical trials/clinical studies.
  • We are a growing diverse team developing and supporting an innovative system where you will make significant contributions to challenging projects using leading edge technology in a collaborative environment.
  • Axiom offers flexible hours. We believe in allowing our creativity to flourish working in a laid-back professional but casual environment. We are jean friendly; every day and we keep an employee lounge stocked with a variety of snacks and coffee.
  • The Company is very team oriented and we believe in celebrating our milestones and colleagues. We often have Company events, luncheons and ice cream days during the summer. We organize community service events and team building outings to promote and celebrate collaboration. We work hard but smart and have a passion for leading edge technology with great customer service.

APPLY FOR THIS POSITION

All interested applicants are requested to submit a resume and cover letter. We thank all applicants in advance for their interest but only those selected for interview process will be contacted. No phone calls or third-party recruiters please.

Axiom is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with a disability.

QUALITY ASSURANCE MANAGER

Full Time, Toronto, ON

Must have prior experience with ISO 9001 & GCP

ABOUT THE ROLE

The Quality Assurance Manager works closely with the CEO and the entire Axiom Team to assure consistent product and service delivery across the organization by developing and enforcing the Axiom Quality Management System, Business Continuity Plan, CAPA, conducting audits, validating processes, providing documentation and training staff.

Candidates must have 2- 4 years’ experience as a Quality Assurance Manager in North America working at a CRO/ Biotech /Pharmaceuticals. Candidates who do not meet this criterion will not be considered for this role.

KEY RESPONSIBILITIES

  • Achieves quality assurance operational objectives by contributing analysis to strategic plans and reviews; preparing and completing CAPA requests; implementing productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements.
  • Accomplishes quality assurance human resource objectives by enforcing SOPS, IWIs, Polices, Guidelines and Procedures
  • Develops quality assurance initiatives by identifying critical process points and preventive measures; establishing critical limits and boundaries, monitoring procedures, corrective actions, and verification procedures
  • Maintains and improves product and service quality by completing product, service, company, compliance, and surveillance audits; assisting Customer Care in investigating customer complaints; collaborating with other members of management to develop new SOPs, IWIs, policies, guidelines, and training methods.
  • Validates quality processes by establishing quality attributes; measuring project delivery and performance; documenting evidence; determining operational and performance metrics; writing and updating documentation related to the Quality Management System.
  • Prepares quality documentation and reports on CAPA Request and Corrective Actions / Preventative Actions.
  • Updates knowledge by studying current trends in and developments in quality management; quality assurance, participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.

REQUIRED EDUCATION & EXPERIENCE

  • Ideally 8+ years’ experience as a Quality Assurance Manager in North America working at a CRO/ Biotech /Pharmaceuticals.
  • Thorough knowledge of industry specific regulatory compliance and frameworks (EU, Health Canada, FDA, cFDA, etc.)
  • A good understanding of ISO:9001
  • Thorough knowledge of GxP
  • Experience in clinical trial process and Process Improvement
  • Excellent Strategic Planning and Analyzing Information skills
  • Strong written and oral communication skills
  • Familiar with GCP
  • Strong attention to detail and desire for completing thorough an accurate work
  • Able to deal with complexity and new requirements in a changing environment

ABOUT THE COMPANY

  • Axiom Real-Time Metrics Inc. is a leading technology company in the clinical trial space. We work with small to medium biotech, pharma and CROs to provide efficient technology platforms to commence and enhance clinical trials/clinical studies.
  • We are a growing diverse team developing and supporting an innovative system where you will make significant contributions to challenging projects using leading edge technology in a collaborative environment.
  • Axiom offers flexible hours. We believe in allowing our creativity to flourish working in a laid-back professional but casual environment. We are jean friendly; every day and we keep an employee lounge stocked with a variety of snacks and coffee.
  • The Company is very team oriented and we believe in celebrating our milestones and colleagues. We often have Company events, luncheons and ice cream days during the summer. We organize community service events and team building outings to promote and celebrate collaboration. We work hard but smart and have a passion for leading edge technology with great customer service.

APPLY FOR THIS POSITION

All interested applicants are requested to submit a resume and cover letter. We thank all applicants in advance for their interest but only those selected for interview process will be contacted. No phone calls or third-party recruiters please.

Axiom is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with a disability.

PROJECT MANAGEMENT ASSOCIATE- CLINICAL OPERATIONS

Toronto, Ontario
Full Time

ABOUT THE ROLE

The Project Management Associate is a member of our Clinical Operations Department and provides daily management of clinical trials and registry projects for clients across the globe. The position combines project management, timeline management, financial management and Axiom application support responsibilities

KEY RESPONSIBILITIES

  • Managing and scheduling interdepartmental and client meetings to inform on project resolutions and updates;
  • Communicating with key internal and external stakeholders about upcoming deadlines and assignments;
  • Overseeing; validating; managing issues, tasks and project documents for the Axiom product configuration;
  • Facilitating, implementing, verifying and operating electronic case report forms.
  • Managing the development of client deliverables including study environments, project management and clinical reports;
  • Overseeing the management of project timelines and milestones projects;
  • Ensuring adherence and compliance to standard operations procedures for projects.

REQUIRED EDUCATION & EXPERIENCE

  • You are smart. You are driven. You like working with others who are smart and driven. You are ready to take your career to the next level in a fast moving and growing organization.
  • Having an interest and curiosity for science and technology, you want to work with an organization that makes a difference in people’s lives, one that truly partners with its employees and its clients; clients who are at the forefront of research in their disciplines.
  • Clinical Research or Project Management Certification or other related discipline is an asset;
  • Entry-level through 2 years of experience;
  • Ability to multitask and prioritize in a fast-paced environment;
  • Ability to communicate in English at a business level, written and verbal;
  • Excellent organizational, time management and interpersonal skills;
  • Team player with strong attention to detail and excellent problem-solving skills;
  • Tech savvy with advanced knowledge of Microsoft Office and the ability to quickly learn our proprietary Fusion eClinical software

APPLY FOR THIS POSITION

All interested applicants are requested to submit a resume and cover letter. We thank all applicants in advance for their interest but only those selected for interview process will be contacted. No phone calls or third-party recruiters please.

Axiom is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with a disability.

ABOUT THE COMPANY

Axiom Real-Time Metrics Inc. is a leading technology company in the clinical trial space. We work with small to medium biotech, pharma and CROS to provide efficient technology platforms to commence and enhance clinical trials/clinical studies.

We are a growing diverse team developing and supporting an innovative system where you will make significant contributions to challenging projects using leading edge technology in a collaborative environment.

Axiom offers flexible hours. We believe in allowing our creativity to flourish working in a laid-back professional but casual environment. We are jean friendly; every day and we keep an employee lounge stocked with a variety of snacks and coffee.

DATA MANAGER
Toronto, Ontario
Full Time

ABOUT THE ROLE

This is a full-time Data Manager position.

Candidates should have 3-5 years’ prior experience working in Data Management at a CRO/ Biotech /Pharmaceuticals. Candidates who do not meet this criterion will not be considered for this role.

The Data Manager is responsible for Data management activities for one or more clinical trial or registry projects, working closely with the Project Manager and the other members of each team.

KEY RESPONSIBILITIES

  • RESPONSIBILITIES RELATED TO PROJECT INITIATION
  • Effective management of all data and reports (management reports and/or clinical data reports) based on project protocol and overall information objectives
  • Assist with implementation and testing of eCRF and reports into Axiom Aware or Axiom Go Cubed Data Capture & Reporting Tools
  • Develop key Data Management documents for presentation to and review by the sponsor
  • Assist where applicable in the development and implementation of site training and ongoing data management related support plans

 

  • RESPONSIBILITIES RELATED TO PROJECT MAINTENANCE
  • Responsibility for all aspects of data management for each study, including issue and resolution of queries where applicable
  • Responsible for ensuring data integrity, performance of edit checks, and recommends applicable changes/updates to the Data Integrity Plan as per Sponsor request/Protocol amendments and/or eCRF updates
  • Follow up on eCRF and query completion with sites
  • Evaluate and add queries to data where applicable based on edit check output
  • Responsible for data transfer configuration and quality assurance of data transfer validation activities
  • Remote site training, support, and communications from a data management perspective
  • Ongoing support for the management of the project and associated ancillary initiatives (e.g. newsletters, data abstracts/manuscripts/presentations, public awareness activities, project expansion, assisting with interim analyses, database lock and coding, etc)
  • Assist, where applicable, with the maintenance of the Axiom Aware or Axiom Go Cubed Clinical Trial Suite application in conjunction with the Project Manager

 

  • RESPONSIBILITIES THROUGHOUT LIFECYCLE OF A PROJECT
  • Data management and data quality assurance
  • Close, ongoing collaboration with members of project team to ensure project runs smoothly and efficiently and that overall strategic objectives are realized

REQUIRED EXPERIENCE & EDUCATION

  • 3-5 years’ experience in CRO/ Biotech/ Pharmaceuticals
  • Working knowledge of clinical/medical/biology terminology.
  • Proficiency in Microsoft Word, Excel, PowerPoint, Project and Outlook
  • or recognized equivalent in Health or Science related field
  • Knowledge of ICH-GCP
  • Experience with EDC systems (data entry and/or configuration)
  • Proficiency in Microsoft Word, Excel, PowerPoint, Project and Outlook
  • Enthusiastic, smart, resourceful, analytical
  • Proven to take initiative.
  • Well-developed written and communication skills
  • Perceptive listening skills
  • Strong attention to detail
  • Time management skills
  • Ability to work independently within a team environment
  • Adept at multi-tasking
  • Basic understanding of web-based technologies and browsers

APPLY FOR THIS POSITION

All interested applicants are requested to submit a resume and cover letter. We thank all applicants in advance for their interest but only those selected for interview process will be contacted. No phone calls or third-party recruiters please.

Axiom is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with a disability.

ABOUT THE COMPANY

Axiom Real-Time Metrics Inc. is a leading technology company in the clinical trial space. We work with small to medium biotech, pharma and CROS to provide efficient technology platforms to commence and enhance clinical trials/clinical studies.

We are a growing diverse team developing and supporting an innovative system where you will make significant contributions to challenging projects using leading edge technology in a collaborative environment.

Axiom offers flexible hours. We believe in allowing our creativity to flourish working in a laid-back professional but casual environment. We are jean friendly; every day and we keep an employee lounge stocked with a variety of snacks and coffee.

The Company is very team oriented and we believe in celebrating our milestones and colleagues. We often have Company events, luncheons and ice cream days during the summer. We organize community service events and team building outings to promote and celebrate collaboration. We work hard but smart and have a passion for leading edge technology with great customer service.

Better decisions. Shorter timelines.
Unified Technology. Unmatched Service.