We are seeking an experienced Clinical Study Manager / Clinical Operations professional to support the planning, execution, and oversight of clinical studies at the country and regional level.

This is a fully remote position, and candidates must be based in Canada. The ideal candidate will have strong experience in pharmaceutical, biotechnology, CRO, or clinical research environments and a solid understanding of end-to-end clinical trial operations.

Key Responsibilities

- Lead and provide operational oversight for assigned clinical studies at the country/regional level from study start-up through study close-out.
- Develop and maintain country-level study plans, timelines, resources, risks, quality activities, and operational deliverables.
- Coordinate with global study teams, local study teams, investigators, CROs, and other internal and external stakeholders.
- Monitor study progress and identify potential risks, delays, gaps, and operational issues; develop and implement appropriate mitigation strategies.
- Support study feasibility, site selection/activation, site performance, recruitment, study conduct, and close-out activities.
- Provide oversight and support to CRO teams and ensure country/site-level deliverables are completed according to timelines and quality expectations.
- Ensure compliance with ICH-GCP, applicable regulations, protocols, and company quality standards.
- Support Risk-Based Monitoring activities and maintain oversight of essential study documentation and eTMF completeness.
- Support regulatory inspections, audits, quality reviews, and corrective/preventive actions.
- Build and maintain strong relationships with investigators,



clinical sites, CRO partners, and internal cross-functional teams.
- Provide study updates, escalate critical issues, and contribute to strategic decision-making within the study team.
- Drive continuous improvement and ensure timely, high-quality delivery of country study commitments.

Required Qualifications
- Bachelor's, Master's, PharmD, MD, PhD, or equivalent degree in Life Sciences, Pharmacy, Medicine, or a related field.
- 3–5+ years of experience in pharmaceutical, biotechnology, CRO, or clinical research operations.
- Strong understanding of end-to-end clinical trial processes.
- Strong knowledge of ICH-GCP and applicable clinical research regulations.
- Experience managing clinical study activities across multiple sites.
- Experience working with investigators, clinical sites, CROs, sponsors, and cross-functional teams.
- Strong problem-solving, influencing, communication, and stakeholder-management skills.
- Ability to manage multiple priorities in a rapid-paced clinical development environment.
- Ability and willingness to travel to clinical sites when required.
- Candidates must be currently residing in Canada.

Preferred Qualifications
- Experience with Phase II and/or Phase III clinical trials.
- Experience with country-level study management or clinical trial leadership.
- Experience with eTMF, CTMS, EDC, and clinical trial management systems.
- Experience with CRO oversight and site performance management.
- Experience with risk-based monitoring, inspection readiness, and quality/compliance activities.
- Project management experience or formal project management training.

📌 Clinical Trial Manager (Mississauga)
🏢 Pharmaceutical
📍 Mississauga