Our client, a leading provider of high-quality pharmacology services, is currently recruiting for a Clinical Project Manager to be based in Rennes, France. With over 25 years of experience in providing scientific and medical services in Early Clinical Development, the company possesses one of the largest clinical capacities in Europe.
- The Clinical Project Manager is responsible for providing customer-focused leadership and project oversight.
- This position facilitates communication among team members, including study monitors, sponsor personnel and the company Project Team.
- The Clinical Project Manager proactively solves issues, and oversees the successful implementation and monitoring of clinical studies to ensure that studies are conducted in accordance with ICH/GCP and applicable regulations.
- Manage and coordinate the activities of clinical trials with the company Project Team.
- Serve as the main point of contact and communicate with sponsors regarding project timelines, updates, needs and emerging issues.
- Develop study timelines based on protocols.
- Ensure project start-up activities by facilitating processes for preparation of regulatory documents, ensuring timely IRB approvals for clinical trials.
- Lead the internal project meetings including Kick-off meetings and Study Initiation meetings, etc. with sponsors/internal teams.
- Organize and coordinate Safety Review Meetings with Investigator / sub-investigator / Medical and scientific affair members.
- Monitor and ensure that project scope and deliverables are fulfilled within timelines and budget.
- Support and coordinate with the Biometrics team to ensure completion of the Clinical Study Report, as applicable.
- Review and manage study contracts/budgets.
- Review and approve Vendor/Site contracts, budgets and invoices.
- Regularly and in a timely fashion, interact with management, sponsors, and/or functional team members on matters concerning resource allocation, project milestones, regulatory issues, and other relevant issues.
- Requires a Bachelor's degree (Masters a plus) in life sciences or related field.
- Minimum 3-5 years of experience in clinical research and knowledge of GCP and EMEA regulatory requirements is required.
- Good understanding of the drug development process.
- Must have previous experience managing projects and in monitoring clinical studies.
- Excellent written and verbal communication skills, as well as interpersonal skills.
- Exceptional time management and conflict resolution skills required.
- Ability to interact with all levels of management, sponsor and study site personnel.
- Detail-oriented and possess good trouble-shooting skills with the ability to prioritize and execute tasks in a high-pressure environment. .
- Occasional travel may be required for bid defense, initiation or kick-off meetings, or other study-related activities.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kellie-Marie Saul on +44 203 823 4366 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.