Clinical Trial Manager - Single Sponsor dedicated

Overview

IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department supports client’s project teams in executing clinical trials. The role is full-time, home-based in France as Clinical Trial Manager, responsible for operational management of trial components and oversight to achieve recruitment, timelines, budget and quality.

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 timely preparation of required trial documents, contracts, and necessary approvals.
• Verify that all Regulatory Requirements are satisfied prior to trial/site initiation.
• Ensure appropriate trial-specific training of CRO internal and external partners in line with Trial Training Plan.
• Collaborate with Site Monitoring Lead and CRAs to provide trial oversight by monitoring compliance with GCP, local regulations, BI SOPs, and adherence to the trial protocol.
• Collaborate with Site Monitoring Lead and CRAs to ensure adequate trial supply distribution, timely data entry and cleaning, and on-time Data Base Lock.
• With Trial Resource Specialist and CRAs, ensure collection of required documents with timely, complete, and compliant archiving 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 and compliance requirements.
• Ensure all tasks are carried out in accordance with applicable SOPs, Business Practices, and regulatory requirements, maintaining high ethical and professional standards.
• Lead local CRO trial team to ensure integrity of trial conduct, patient safety, and that the local component is planned, conducted, and reported in line with regulatory requirements; orchestrate collaboration with other functions as needed.
• Work within a complex GCP and regulatory environment on global clinical trials with multidisciplinary, international teams and multiple stakeholders including suppliers and investigational sites.

Required Knowledge, Skills and Experience

• Master’s or higher-level degree in life sciences (preferable).
• Long-term experience in clinical research, including at least 2 years of clinical trial management and monitoring experience in France.
• Proven experience in site relationship management.
• Exceptional knowledge of applicable clinical research regulatory requirements (GCP, ICH guidelines).
• Excellent understanding of project financials and vendor management.
• Effective communication skills; fluent in English and French.
• Strong ability to work on abstract topics, strategic thinking, and solution orientation.
• Excellent organizational, planning, time management, and prioritization skills across multiple projects.
• Leadership and collaboration skills with the ability to build effective working relationships with coworkers, managers, and clients; ability to influence in matrix structures.
• High accountability, commitment, and growth mindset to drive change.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Flexibility for occasional business travel for client meetings.
• Ability to make decisions and provide clarity to disparate information to drive actions and results.