Clinical Trial Manager – Single Sponsor Dedicated

This is a fully remote position, open to applicants in France.

📋 Description

• Execute the clinical trial in accordance with the clinical trial protocol, adhering to timelines, and ensuring compliance with ICH-GCP and all relevant external regulations.

• Lead and assist the local trial team and investigative sites in the prompt preparation of necessary trial documents, contracts, and approvals.

• Verify that all Regulatory Requirements are fulfilled before trial/site initiation.

• Provide appropriate trial-specific training to both internal and external partners of the CRO, following the Trial Training Plan.

• Collaborate with the Site Monitoring Lead and CRAs to ensure effective trial oversight by monitoring trial sites' and teams' compliance with GCP, local regulations, BI SOPs, and adherence to the trial protocol.

• Work together with the Site Monitoring Lead and CRAs to ensure sufficient trial supply distribution to sites, timely data entry and cleaning, and adherence to the Data Base Lock schedule.

• Partner with the Trial Resource Specialist and, as needed, support from CRAs to gather required documents, ensuring timely, complete, and compliant archiving of all pertinent documents for the eTMF and CTR Appendices.

• Build and maintain relationships with investigational sites while supporting CRAs in site communications.

• Report to and update Clients, exchanging critical information and sharing trial execution details while adhering to regulatory and compliance requirements.

• Ensure that all tasks are performed in compliance with applicable SOPs, Business Practices, and regulatory standards.

• Maintain the highest ethical and professional standards in all interactions and engagements.

• Lead the local CRO trial team to ensure the integrity of trial execution, the safety of patients, and compliance with regulatory requirements throughout the planning, conducting, and reporting of the local trial component.

⛳️ Requirements

• A Master’s or higher-level degree in a life science discipline.

• Extensive experience in clinical research, including a minimum of 2 years in clinical trial management and monitoring experience specifically in France.

• Demonstrated proficiency in managing site relationships.

• In-depth knowledge of relevant clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Strong understanding of project financials and effective vendor management strategies.

• Excellent communication skills, with fluency in both English and French.

• Strong ability to abstract complex topics, engage in strategic thinking, and maintain a solution-oriented approach.

• Outstanding organizational and planning capabilities, along with time management and prioritization skills while handling multiple projects.

• Proficient computer skills, including working knowledge of Microsoft Word, Excel, and PowerPoint.

• Willingness to travel occasionally for business meetings with clients.

🏝️ Benefits

• Opportunities for professional development.

• Flexible working arrangements.