Study Operations Manager I

ICON Strategic Solutions; France; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A global strategic solutions company is looking for a Study Operations Manager I in France. You will be responsible for managing study activities from start-up to close-out, ensuring compliance with ICH/GCP and local regulations. The ideal candidate should have a minimum of 3 years of clinical trial operations experience and strong communication skills. This position offers an opportunity to lead local investigations and drive operational timelines.

Qualifications

• Minimum 3 years of clinical trial operations experience required.
• Strong knowledge of ICH/GCP and local regulatory requirements is essential.
• Fluency in English is mandatory.

Responsabilités

• Oversee study start-up, conduct, and close-out at assigned country level.
• Manage vendors and coordinate deliverables, including quality and site performance.
• Provide input on risk assessment, timelines, and study budgets.

Connaissances

Clinical trial operations experience

Excellent communication skills

Problem-solving skills

Managing timelines and risks

Vendor and site management

Outils

Study management tools

Reporting systems

Description du poste

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.
  

#LI-KD1