Clinical Trial Manager – Single Sponsor Dedicated

Role Overview

• Deliver the trial according to the clinical trial protocol, within trial timelines, and in compliance with ICH-GCP and all other relevant external regulations.
• Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts, and necessary approvals.
• Check 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.
• In collaboration with Site Monitoring Lead and CRAs, ensure provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and team to GCP, local regulations, BI SOPs, and adherence to trial protocol.
• In collaboration with Site Monitoring Lead and CRAs, ensure adequate trial supply distribution to sites and timely data entry and cleaning, and on time Data Base Lock.
• In collaboration with Trial Resource Specialist and with support from CRAs as appropriate, ensures collection of required documents, with timely, complete, and compliant 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 and compliance burdens.
• Ensures all tasks are carried out in accordance with respective applicable SOPs, Business Practices, and regulatory requirements. Ensures that all interactions and engagements are carried out with the highest ethical and professional standards.
• Leads local CRO trial team to ensure integrity of trial conduct, assurance of patient safety, and that local component of trial is planned, conducted, and reported in line with regulatory requirements.
• Works within a complex GCP and regulatory environment and on global clinical trials with multidisciplinary, international teams and with various internal and external stakeholders including suppliers and investigational sites.

Requirements

• Master’s or higher-level degree preferable in life science.
• Long term experience in clinical research, including at least 2 years of clinical trial management experience and monitoring experience in France.
• Proven experience in site relationship management.
• Exceptional knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Excellent understanding of project financials and effective vendor management.
• Effective communication skills, fluent language skills in English and French.
• High ability to work on abstract complex topics and to strategic thinking, as well as solution orientation.
• High organizational and planning skills, time management and prioritization skills while working on multiple projects.
• Excellent leadership and collaboration skills, and the ability to establish and maintain effective working relationships with coworkers, managers and clients.
• High degree of self-accountability and commitment and a strong growth mindset to drive change and contribute actively to future leading transformation.
• Very good computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Flexibility to occasional business travel for client meetings.
• Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.

Tech Stack

• Google Cloud Platform

Benefits

• Flexible working arrangements
• Professional development opportunities