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Clinical Project Manager - France, United States
Posted on : 08 May 2017
- 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.
Under the supervision of the Head of Clinical Operations, duties and responsibilities relative to the management of Clinical Research studies will include, but will not be limited to:
- 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.