Study Operations Manager I

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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