Clinical Trial Manager - Single Sponsor dedicated

Clinical Trial Manager - Single Sponsor dedicated

Courbevoie, France | Full time | Home-based

Overview

The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department supports the client’s project team in executing clinical trials. The role involves operational management of components of clinical trials, ensuring recruitment, timelines, budget and quality standards (Trial Preparation, Conduct and Closeout).

Responsibilities

• Deliver the trial according to the clinical trial protocol, within timelines, and in compliance with ICH-GCP and relevant regulations.
• Lead and support local trial team and investigative sites in preparation of required trial documents, contracts, and approvals.
• Verify Regulatory Requirements are satisfied prior to trial/site initiation.
• Ensure appropriate trial-specific training of CRO internal and external partners per Trial Training Plan.
• Provide trial oversight with Site Monitoring Lead and CRAs, monitoring compliance with GCP, local regulations, BI SOPs, and trial protocol.
• Coordinate trial supply distribution to sites, timely data entry and cleaning, and on-time Data Base Lock.
• Ensure collection of required documents and timely, complete archiving of all relevant documents for the eTMF and CTR Appendices.
• Develop and maintain relationships with investigational sites and support CRAs in site contacts.
• Report and provide client updates, exchange critical information, and share trial conduction information within regulatory requirements.
• Ensure tasks are carried out in accordance with applicable SOPs, Business Practices, and regulatory requirements, maintaining ethical and professional standards.
• Lead local CRO trial team to ensure integrity of trial conduct, patient safety, and alignment with regulatory requirements; coordinate with other functions as needed during planning, conduct, and closeout.
• Collaborate with global, multi-disciplinary teams and external stakeholders, including suppliers and investigational sites.

Qualifications

• Master’s degree or higher in life sciences preferred.
• Experience in clinical research with at least 2 years of clinical trial management and monitoring experience in France.
• Proven site relationship management experience.
• Comprehensive knowledge of regulatory requirements (GCP, ICH).
• Strong understanding of project financials and vendor management.
• Excellent communication skills with fluent English and French.
• Strong ability to work on complex topics, strategic thinking, and solution orientation.
• Excellent organizational, planning, time management and prioritization skills across multiple projects.
• Leadership and collaboration skills; ability to influence partners in matrix structures.
• Self-accountability with a growth mindset to drive change.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Ability to travel occasionally for client meetings.
• Decision-making capability with clarity across complex information to drive actions and results.