Clinical Project Manager - France, United States
- 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.
- Follow screening and recruitment activities to ensure timely enrollment in the studies.
- 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. Collaborate with Billing and Accounts Department to ensure billing is in agreement with pre-established milestones.
- 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.
- Organize sponsors' visit of the Unit (Site qualification visits, Initiation Meetings, Monitoring visits and Close-out visits)
- Occasional travel may be required for bid defense, initiation or kick-off meetings, or other study-related activities.
- 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 FDA 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.
- CCRC certification preferred.
- Proficient computer skills in Microsoft Office Suite.