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.

Clinical Project Manager

Axiom, an innovative leading-edge technology provider in the life sciences sector has an opportunity available for a Clinical Projects Manager to join its team.

Summary of Role.

Key roles as an Axiom Clinical Project Manager are:

  • 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
  • Financial Management of projects; ensuring Scope of Work remains on track
  • Coaching and development of Clinical Management Team members
  • Writing of Axiom Real Time Clinical SOPs
  • Contribute to innovative solutions to enhance Axiom Clinical Management processes

 

Responsibilities and Duties

Project Management.

  • Management of Project Milestones and Timelines
  • Review and create study documentation and provide expertise in GCP
  • Manage project-related issues
  • Coordination and management of internal and client meetings
    • Development and production of meeting support materials
    • Web-based or on-site meeting support
    • Internal meetings with various teams / Data Management / Pharmacovigilance / Customer Care, etc.

 

Clinical Trial Management.

  • With supervision, assess study feasibility, contribute to study design elements, and collaborate with project team to review and provide input on protocols for clinical studies.
  • Support training investigators, research coordinators, internal staff , central laboratories, central imaging, and other study vendors on study related procedures.  Support providing first tier support for protocol, SOPs, and systems.
  • With supervision, plan, manage, and report all aspects of global clinical studies through oversight of cross-functional study activities.
  • With supervision, create and report clinical study updates to management on a regular basis; report on performance to plan.
  • Coordinate and oversee clinical studies to support regulatory submissions (IDE, PMA, 510(k) and Post Market Surveillance); assist in preparation of clinical study reports, regulatory documents and submissions as directed.
  • Independently monitor, and/or assist CRAs with monitoring activities, to ensure compliance with study protocols, regulatory requirements, and procedures.
  • Follow current SOPs.  Assist in the evaluation of current procedures for efficiencies and quality as well as make recommendations to management for improvements.
  • Independently organize and lead internal and external meetings with associated communications and materials.
  • With supervision, contribute to scientific publications in international peer-reviewed journals and other publications, conferences, and other media as appropriate and present at client Investigators’ meetings

 

Qualifications and Skills

  • 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
  • Proficient in MS Office Suite

 

Ideal Education & Experience 

  • 7-8 Year’s experience in a pharmaceutical or CRO environment
  • or recognized equivalent in Health or Science related field
  • Project Management courses
  • Clinical Research Postgraduate Certificate
  • Clinical professional degree e.g. CCRP accreditation
  • Knowledge of ICH-GCP

Experience with EDC systems (data entry, report review, query resolution and/or configuration)

 

Benefits

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

Position Type and Core Hours.

  • This a full-time position, days and hours of work are Monday through Friday 9:00am-5:00pm.

SOFTWARE DEVELOPER (C+ .NET)

JOB FUNCTION OVERVIEW

As a Software Engineer you will be trained on Axiom technology and be responsible for working with Senior Axiom Development team members on key implementations. Working in the team in accordance with project schedules, you are a confident developer with skills and experience in C# and ASP.NET using Visual Studio .NET. Your strength in SQL Server enables you to develop optimized stored procedures and user defined functions.

KEY RESPONSIBILITIES

 • Developing custom code specific to individual studies
 • Deploying and maintaining studies developed with the Axiom Fusion eClinical Suite
 • Participate in the planning and design of new modules, features and applications
 • Write thorough test plans for areas of the application
 • Recognize and recommend areas that would be candidates for automated testing
 • Be responsible for performing unit testing to ensure the quality of each project that you work on 
 • Will be responsible for supporting the client study / application throughout the duration of the study and addressing application related issues (bugs, fixes, upgrades etc.)
 • Work extensively with other members of the development and support teams, using your analytical and problem-solving abilities to push the boundaries and develop new solutions

WHAT YOU BRING TO THE TABLE

 • Minimum 3-5 years’ experience developing with C# .NET (Microsoft Windows Stack) and developing complex web applications
 • Knowledge of verification and validation techniques 
 • Knowledge of JavaScript and jQuery is required
 • Proficient in T-SQL
 • Project experience in software testing practices, methodologies, particularly within the software industry (regression, performance, stress and load)
 • Proven ability to work effectively with cross-functional teams in a fast-paced, dynamic environment
 • Experience with Microsoft Windows operating systems (Windows 10, Windows Server) 
 • Experience with knowledge of IIS, SQL Server, .NET applications 
 • Must have good oral and written communication skills 
 • Must be a self-starter and a quick learner with attention to detail and the ability to balance multiple tasks and deadlines
 • Experience in Health Care
 • Experience with the clinical trial process
 • Understanding of industry specific regulatory compliance and frameworks

 

 

Clinical SAS Programmer

Summary
We are seeking a Clinical SAS Programmer to contribute to the preparation, validation and maintenance of SAS programs to generate SDTM and ADaM SAS datasets, specifications, tables, Listings, Figures and graphical displays of clinical trial and safety data.
The position is also responsible for developing SAS programming codes and generating complete and accurate statistical output reports of trial data in well-defined formats
Key Responsibilities:
 • The incumbents will be responsible for performing statistical programming, validation, and quality control of the SDTM and ADaM datasets and output tables/listings/graphs:
 • Design and specification of study data tabulation models and analysis data models;
 • Generate complete and efficient analysis data models following approved dataset designs or specifications.
 • Develop SAS programming codes to independently validate statistical output reports of trial data generated by other programmers or statisticians.
 • Writes, validates and maintains SAS programs to generate SAS datasets, spreadsheets, ASCII files, data listings, tables and graphical displays of clinical trial and safety data.
 • Contribute to the establishment of client specific programming standards/conventions/procedures for assigned clients when required.
Qualifications
 • Bachelor’s Degree in a related field required (e.g. Statistics, Computer Science), Masters preferred.
 • Proven SAS experience and expertise as demonstrated in previous work (SAS certification is an asset).
 • Extensive knowledge of CDISC standards programming – SDTM and ADaM.
 • An understanding of relevant safety and efficacy ICH guidelines as well as relevant clinical trials regulations.
 • Experience with relational databases.
 • Demonstrated leadership ability to effectively manage statistical programming activities and integrate them with the entire clinical trial operation.
 • Good organizational and time management skills with the ability to manage concurrent projects and adjust to changing priorities.
 • Detail-oriented, customer- and quality-focused.
 • Excellent interpersonal skills; Demonstrated ability to work independently and as part of a team.
 • Proven flexibility and adaptability when working in a team and independently, using good judgment in making decisions.

IWRS Associate

ABOUT THE COMPANY

Axiom, an innovative leading-edge technology provider in the life sciences sector has an opportunity available for an IWRS Associate to join its team!

Summary of Role.

Randomization is the heart of any randomized clinical trial and the importance of accurate accountability of the investigational products has gained significantly in recent years. The IWRS Associate is an integral part of the Axiom team supporting the randomization and inventory aspects of a Clinical Trial, ensuring the technology and services meet the Client requirements.

This role participates in the study start-up activities by gathering requirements, authoring key module documents and assisting with module configuration and validation. During active enrollment, this role monitors randomizations and inventory levels and investigates / escalates end-user scenarios in preparation for a smooth closeout.

This role works closely with the IWRS Lead and IWRS Team Members, as well as Software Engineers, Project Management, Data Management, Customer Care and Quality Assurance. This role is comfortable working in a fast-paced, dynamic environment and maintains the highest caliber of work.

This role reports to the IWRS Lead.

Responsibilities and Duties

  • Development of key IWRS documents to define module requirements and blinding needs
  • Module & Report design, configuration and validation and development of supporting materials
  • End-user issue management, working with the Project Management and Customer Care Teams to respond to IWRS-related end-user inquiries
  • Monitoring of ongoing randomizations to ensure that the subjects are receiving the correct treatment and identifying dispensing scenarios
  • Ensuring that the required inventory is on site prior to scheduled visits through daily monitoring, issue escalation and raising manual requests as applicable

Qualifications and Skills

  • 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
  • Proficient in MS Office Suite

Ideal Education & Experience

  • BSc. or recognized equivalent in Health or Science related field
  • Clinical Research Postgraduate Certificate
  • Knowledge of ICH-GCP
  • Experience with EDC systems (data entry and/or configuration)
  • Experience in health-care / pharmaceutical industry
  • 1 year of experience working with IWRS / IVRS / ERP systems (randomization and / or inventory management)
  • 1 year in a professional service environment
  • Basic understanding of web-based technologies and browsers

Benefits

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

Position Type and Core Hours.

  • This a full-time position, days and hours of work are Monday through Friday 9:00am-5:00pm.

Apply for this position

All interested applicants are requested to submit a resume and cover letter to careers@axiommetrics.com . 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.

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