RTSM (IWRS) Associate

Toronto, ON – Full Time

ABOUT THE ROLE

The RTSM (IWRS) Associate 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 RTSM (IWRS) Team, as well as Software Engineers, Project Management, Clinical 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.

KEY RESPONSIBILITIES

• Development of key RTSM 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 RTSM-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 review, issue escalation and raising manual requests as applicable
• Assisting with Project Management related activities such as internal/external communications, coordination and management of meetings, project planning and tracking of timelines and deliverables

REQUIRED EDUCATION & EXPERIENCE

• BSc. or recognized equivalent in Health or Science related field preferred
• Clinical Research Postgraduate Certificate and / or knowledge of ICH-GCP preferred
• Experience with EDC systems (data entry and/or configuration)
• Experience in healthcare/pharmaceutical industry
• 1 year 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
• Proficient in MS Office Suite

Senior Server and Network Administrator

Toronto, Ontario – Full Time

ABOUT THE ROLE

The Senior Server & Network Administrator is responsible for Server, Network and Security Support.

Candidate must have 5+ years’ experience in Server / Network Support. Candidates who do not meet this criterion will not be considered for this role.

KEY RESPONSIBILITIES

• Take the lead for all Production and Development environment server support (AWS & VMware environment).
• Take the lead for all Production and Development backup processes and responsible for yearly testing.
• Take the lead for all Firewall configuration and support.
• Take the lead for all internal networking design and configuration with direction from IT Management.
• Work with IT Management to continuously improve IT security posture and processes.
• Work on escalated incidents.
• Assist other team members for service requests and or incident tickets.
• Take the lead for management of Active Directory.

REQUIRED EXPERIENCE & EDUCATION

• 5+ years’ experience in Server / Network Support.
• Bachelor’s or Master’s Degree in Computer Science, Information Science or Management Information Systems.
• 5+ years of experience providing 2nd and 3rd level infrastructure support is considered an asset.
• 5 + years’ experience managing and supporting AWS environments.
• AWS Certifications.
• AWS Certified Cloud Practitioner.
• AWS Certified Solutions Architect.

Software Engineer

Full Time

ABOUT THE ROLE

As a Software Programmer 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

REQUIRED EDUCATION & EXPERIENCE

• 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

Product Innovation Associate

Toronto, Ontario – Full Time

ABOUT THE ROLE

The Product Innovation Associate assists in day-to-day development of Axiom Fusion Technologies focused on User Experience (UX) design.

KEY RESPONSIBILITIES

• Work as part of a team focused on user experience (UX), designing, testing, and documenting new technology and features.
• Gather input from various functional groups, clients, and the market to enhance Axiom Fusion Technology.
• Responsible for assisting in tracking and meeting internal deliverables.
• Write supporting documentation and user guides to support end users.

REQUIRED EDUCATION & EXPERIENCE

• Should have a University Degree (i.e. BSc, BA) or a College Equivalent
• Strong attention to details.
• Excellent verbal and written communication skills.
• Well-developed time-management and organizational skills, with an ability to use judgement in task prioritization
• Ability to work independently and in a team environment.
• Proficient in Microsoft Word, Excel, Power Point, Project and Outlook.
• Understanding of web-based technologies and browsers
• Internships and / or experience in the following are assets:
  • Technology, Pharma or Healthcare Industries
  • EDC, CRM, or CTM Systems (use of, UX, or configuration)
  • Mobile / Web-based Applications (UX / configuration)
• Smart, driven, solutions-oriented, with a knack for problem solving and a habit of taking initiative.

Clinical Project Manager

Southern California (Orange County/San Diego) – Full-Time

ABOUT THE ROLE

The Clinical Project Manager is a full-time role and will oversee all Project Management activities pertaining to a study including study start-up, study initiation, study conduct and close-out; and the implementation of process improvements to facilitate and improve quality of clinical management team. This position reports to the Director of Clinical Management.

Candidates must have 7+ years of experience with North America in Technology, Pharma or Healthcare Industries. Candidates who do not meet this criterion will not be considered for this role.

KEY RESPONSIBILITIES

• Independent oversight of all Project Management activities pertaining to a study; Study Start Up, Study Initiation, Study Conduct 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 and working to oversee these groups to achieve study milestones
• Financial Management of projects; ensuring Scope of Work remains on track and that study remains within agreed upon contract and budget.
• Coaching and development of Clinical Management Team members and mentoring of more junior staff
• Writing of Axiom Real Time Clinical SOPs and review of other departmental SOPs to ensure consistency with clinical processes
• Creation and review of protocol/study design, case report forms (CRFs), source documents, CRF completion guidelines, informed consent forms and other study documents
• Performs direct project tasks such as site monitoring, management/oversight of regulatory and IRB/IEC/REB submissions and/or grant payments as required
• Develops patient recruitment strategies and materials
• Coordinates Clinical Monitors on-site and in-house monitoring responsibilities, schedules and overall project related day-to-day management of the monitoring team to ensure protocol/ICH/GCP/ISO-14155 adherence
• Manages aspects of the clinical projects including development of the Clinical Monitoring Plan (CMP) and the review and sign-off of monitoring reports (including tracking of reports and assurance of visit frequency per CMP/contract).
• Ensures study master files comply with SOPs, GCPs and other regulations.
• Designs and develops investigator, regulatory, operations, guidelines and training manuals.
• Contributes to business development by attending meetings with potential sponsors; contributes time and cost estimates (and/or reviews draft proposals for feasibility) for clinical management related activities.
• Provides financial management of assigned projects and provides monthly updates on progress and performance.
• Oversees scope of study tasks in order to identify any change and support change order process, if required.
• Monitors the preparation and timely completion of all regulatory filing packages and trip reports and reviews them for appropriate content.

REQUIRED EDUCATION & EXPERIENCE

• 7-8+ years in a clinical research or recognized equivalent in Health or Science related field
• Must have experience in pharmaceutical or CRO industry
• At least 2 year in a management / team leader role
• Working knowledge of clinical / medical / biology
• Proficiency in Excel, Word, PowerPoint, Project and Outlook
• Knowledge of ICH-GCP
• Clinical Research Postgraduate Certificate, Clinical professional degree e.g. CCRP accreditation is considered an asset
• Experience with EDC systems (data entry, report review, query resolution and/or configuration) is considered an asset
• Prior project management experience with a CRO is considered an asset

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 EDUCATION & EXPERIENCE

• 3-5 years’ experience in CRO/ Biotech/ Pharmaceuticals
• Working knowledge of clinical/medical/biology terminology.
• Proficiency in Microsoft Word, Excel, PowerPoint, Project and Outlook
• BSc. 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

Clinical Supply Manager

Toronto, Ontario – Full-Time

ABOUT THE ROLE

The 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 etc.

REQUIRED EDUCATION & EXPERIENCE

• 6-8 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