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 fast-paced clinical development workplace.

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