Project Manager I, RWE
New
CanadaFull-TimeEntry
Salary not disclosed
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Job Details
- Required Skills
- Project ManagementMicrosoft Office
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Nursing, or a related discipline (or equivalent experience).
- Experience in clinical research, pharmaceutical, biotechnology, or CRO environments is strongly preferred.
- Strong understanding of ICH-GCP guidelines and applicable regulatory requirements.
- Excellent organizational and project coordination skills with the ability to manage multiple priorities.
- Strong communication skills, both written and verbal, with the ability to interact effectively with internal teams and external stakeholders.
- Ability to work independently while maintaining attention to detail in a fast-paced environment.
- Proficiency in Microsoft Office tools (Word, Excel, PowerPoint) and familiarity with clinical systems is an asset.
- Strong analytical mindset with the ability to support financial tracking, reporting, and study performance analysis.
- Willingness to travel up to 25% if required.
Responsibilities
- Coordinate and monitor study activities across internal functional teams and external vendors to ensure timely and high-quality delivery of RWE study milestones.
- Maintain and oversee Trial Master File (TMF) management plans, ensuring inspection readiness, completeness, and compliance.
- Support study operational activities including database snapshots, interim analyses, study closeout, and final reporting.
- Assist in vendor identification, contracting, performance tracking, and management of deliverables, including oversight of scope changes.
- Contribute to financial tracking, invoice review, budget monitoring, and reporting activities across assigned studies.
- Develop and maintain study metrics, reports, and documentation for internal leadership and client communication.
- Support risk mitigation planning, contingency strategies, and issue resolution to ensure study objectives are met.
- Participate in internal and external meetings, including client interactions and study progress updates.
- Support training activities and contribute to knowledge sharing within the project team.
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