Clinical Trial Manager I

2 weeks ago

Mississauga, Ontario, Canada Alexion Pharmaceuticals,Inc. Full time

Location:
Mississauga, Canada

Job reference:
R-198638

Date posted: 05/02/2024

This is what you will do:

  • Support the CPLs and CTMs for business administrative tasks, especially for trial master file creation, maintenance, closure, and transfer for a single product and multiple studies per company or CRO SOPs. Handle centralized business process tasks, e.g., CDA generation, submission of insurance documentation, safety letter tracking, CSR appendix generation, patient safety cards procurement to support the study.
Manage all Safety Reports in TMF and Investigator portal systems, including QC, distribution and tracking.

You will be responsible for**:

  • Ensuring clinical study document compliance and submission to the TMF throughout the study's life cycle.
  • Ensuring that project documents are maintained per relevant Standard Operating Procedures (SOPs)/Work Instructions (WIs).
  • Serving as a content manager for studyspecific internal work spaces.
  • Procuring, printing and distributing patient safety cards in multiple languages for use across studies.
  • Serving as CIOMS coordinator to track and update log of investigator letters against Investigator Brochure.
  • Coordinate delivery of documents to support registration of a protocol in and monitor its update throughout a study.
  • Act as central point of contact for vendor providing this service.
  • Entering, tracking and routing contracts for legal input and approval using business systems and internal work spaces.
  • Providing administrative support around and assembly of presentations forInvestigator, CRO/vendor kickoff meetings as required.
  • May attend cross functional meetings for initiatives in conjunction with the Center of Excellence.

You will need to have:

  • 2 years of clinical research experience or coursework equivalent in clinical research.
  • Strong verbal, written, and organizational skills with a teamoriented approach and the ability to handle multiple tasks to meet deadlines in a dynamic environment.
  • The duties of this role are generally conducted in an office environment. As is typical of an officebased role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer
for you to have:

  • Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development
  • Research certification desirable
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