Job Title: Country Study Manager (CSM)/Clinical Study Manager

Location: Remote – Canada

Duration: 12 Months

Job Description:

The Country Study Manager (CSM) provides leadership and operational oversight for assigned clinical studies at the country/regional level across study start-up, conduct, and close-out. The CSM is accountable for time, quality, cost, compliance, risk management, and country-level study delivery and works closely with global study teams, CROs, investigators, and cross-functional stakeholders.

Top Responsibilities

- Lead and oversee assigned clinical studies at the country/regional level.
- Manage country-level timelines, budgets, resources, risks, and quality plans.
- Lead local study teams and represent Country/Regional Clinical Operations on global study teams.
- Oversee CRO performance, site relationships, study feasibility, and site monitoring.
- Develop and oversee Risk-Based Monitoring plans.
- Ensure eTMF completeness, GCP compliance, inspection readiness, and CAPA completion.
- Identify study risks/deviations and implement appropriate mitigation strategies.
- Support regulatory inspections, audits, quality/compliance reviews, and other country-level activities.
- Build and maintain strong relationships with investigators, sites, CROs, and internal stakeholders.
- Support Therapeutic Area activities, investigator/site development, and cross-functional initiatives as required.

Top Requirements

Must Have

- 3–5+ years of Pharmaceutical Clinical Operations experience.
- Strong understanding of end-to-end clinical trial processes.
- Experience managing clinical studies at the country/regional level.
- Experience with site relationships and complex clinical trials.




- Strong knowledge of clinical trial regulations and GCP/ICH guidelines.
- Experience working with CROs and cross-functional study teams.
- Strong strategic leadership, problem-solving, and critical-thinking skills.
- Strong communication, influencing, and negotiation abilities.
- Life Sciences degree or equivalent; MD, PhD, MA/MS, or BA/BS.
- Fluent in English and the language(s) of the host country.
- Must be based in Canada.
- Willingness and ability to travel to clinical sites as required.

Nice to Have

- Project management experience.
- Experience with Global/Regional clinical studies.
- Experience with study planning, Risk-Based Monitoring, eTMF, audits, and regulatory inspections.
- Experience serving as a Country Study Representative (CSR).

Key Success Areas

The successful candidate should be able to:

- Take independent ownership of country-level study operations.
- Manage multiple priorities in a fast-paced environment.
- Lead through ambiguity and collaborate effectively across functions.
- Identify and resolve study issues using sound clinical and operational judgment.
- Build robust relationships with sites, CROs, investigators, and internal stakeholders.
- Deliver country-level study commitments with a focus on quality, compliance, timelines, and cost.

First 60 Days

Days 1–15: Complete required training, obtain system access, understand the assigned Therapeutic Area/studies, and align on transition goals.

Days 16–30: Complete study onboarding, understand the FSP model and study team roles, establish escalation/support channels, and complete handover activities.

Days 31–60+: Take autonomous ownership of day-to-day study operations, manage escalations, support end-to-end study delivery, and execute country-level deliverables.

📌 Clinical Trial Manager (Canada)
🏢 Integrated Resources, Inc ( IRI )
📍 Canada