Clinical Data Manager

DATA MANAGER-- Clinical Trials

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
• 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
• 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.