About the job Study Operations Manager I
Job Title: Study Operations Manager I
Job Location: France
Job Location Type: On-site
Job Contract Type: Permanent
Job Seniority Level: Mid-Senior level
The Study Operations Manager I is responsible for managing study activities at country level (France) from start-up through close-out. This role supports one or more studies of limited complexity or specific parts of larger studies, ensuring operational delivery in line with ICH/GCP, SOPs, and local regulations. The position collaborates with cross-functional teams and vendors to drive study timelines, quality, and compliance.
Oversee study start-up, conduct, and close-out at assigned country or study level.
Implement start-up and recruitment strategies in coordination with local and global teams.
Serve as the primary operational contact for the local study team.
Manage vendors and coordinate deliverables, including quality, data, and site performance.
Ensure regulatory, ethics, and protocol compliance at all times.
Provide input on risk assessment, timelines, and study budgets.
Maintain oversight of essential documents, systems, and trial master files.
Support implementation of study tools, technologies, and decentralized trial options.
Lead or contribute to local investigator meetings and operational initiatives.
- Clinical trial operations experience (min 3 years); vendor and site management experience is a plus.
Strong knowledge of ICH/GCP and local regulatory requirements.
Proven ability to manage timelines, risks, and deliverables in a matrix environment.
Excellent communication and problem-solving skills.
Proficiency in study management tools and reporting systems.
Fluent in English.
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