Country Study Manager (Life Sciences)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Country Study Manager (Life Sciences): Leading the planning, execution, and delivery of clinical studies across the full lifecycle with an accent on regulatory compliance, CRO oversight, and stakeholder management. Focus on driving operational excellence, mitigating study risks, and ensuring adherence to GCP standards throughout the trial process.
Location: Must be based in Canada (Remote)
Salary: $50,000–$70,000
Company
is an independent technology consulting firm providing guidance and solutions across Information Systems, Telecom, Life Sciences, and Engineering to clients globally.
What you will do
- Lead and oversee assigned clinical studies from preparation through close-out.
- Develop and monitor country and study-level plans, including timelines, budgets, and quality standards.
- Coordinate study execution with CROs and provide performance oversight.
- Identify study risks and implement effective mitigation strategies.
- Ensure compliance with GCP, regulatory guidelines, and internal quality procedures.
- Represent regional clinical operations within global study teams.
Requirements
- Must be based in Canada.
- Bachelor's, Master's, PhD, or MD in Life Sciences or a related field.
- Proven experience in the pharmaceutical, biotechnology, or clinical research industry.
- In-depth knowledge of clinical trial regulations and Good Clinical Practice (GCP).
- Strong project management and stakeholder management skills.
- Professional proficiency in English required.
Nice to have
- Experience representing regional operations in global study teams.
- Background in supporting regulatory inspections and quality audits.
- Knowledge of Risk-Based Monitoring (RBM) and eTMF management.
Culture & Benefits
- International environment with over 110 nationalities represented.
- Access to an internal Academy with over 250 training modules.
- Dynamic work environment with regular team-building events.
- Commitment to diversity, inclusion, and equal opportunity.
Hiring process
- Initial brief virtual or phone conversation.
- Approximately 3 interviews with line managers and team members.
- Potential case study or technical assessment depending on the role.
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