Project Manager I, RWE
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Project Manager I, RWE based in Canada.
This role focuses on the coordination and delivery of real-world evidence (RWE) study operations within a clinical research environment, supporting the successful execution of observational and post-market research projects. You will manage study activities across multiple internal teams and external vendors, ensuring timelines, quality standards, and regulatory compliance are consistently met. The position plays a key role in maintaining trial master file (TMF) readiness, supporting financial tracking, and contributing to study reporting and milestone delivery. You will also collaborate with stakeholders to ensure smooth study execution, risk mitigation, and operational efficiency. In addition to project oversight, you will contribute to vendor management, resource coordination, and process improvements across studies. This is a highly collaborative, detail-oriented role ideal for professionals who thrive in structured, data-driven clinical environments.
Accountabilities
- 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.
- 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.
- Competitive compensation aligned with experience in clinical project management roles.
- Comprehensive health, dental, and vision insurance coverage.
- Flexible work arrangements supporting remote collaboration.
- Career development opportunities within global clinical research programs.
- Exposure to real-world evidence studies and innovative healthcare research methodologies.
- Training programs and continuous learning support in clinical operations and project management.
- Inclusive, collaborative work environment focused on improving patient outcomes.