Clinical Trial Operations Lead
1 day ago
We are seeking a highly skilled Clinical Trial Manager to lead the planning, implementation, and execution of global clinical trials. Reporting directly to the Chief Medical Officer, you will bring strong collaboration, vendor management, and project management skills to this critical clinical operations role.
The ideal candidate will have a strong background in clinical operations, with experience in managing clinical trials from start-up through close-out. You will be responsible for ensuring that all components of the trial deliverables are executed to specified quality standards.
Key Responsibilities:
- Manage clinical trials from start-up through close-out
- Ensure clear internal communication, process documentation, and coordination of relevant work
- Act as main point of contact for external vendors and foster effective communication with all internal and external stakeholders
- Contribute to the development and implementation of study-related documents
- Proactively manage and track the project scope and change orders
- Monitor the status of clinical data collection and the progress of clinical activity
- Oversee the resolution of data quality issues
Requirements:
- Bachelor's degree in life sciences, nursing, health field, or similar
- 5-10+ years of experience working in clinical operations with an early-stage biotech or similar organization
- Biologics and/or cell therapy experience is highly preferred
- Early-phase clinical trial experience, including IND/CTA submissions is required
- Strong knowledge of best practices in clinical operations methodologies, systems, and processes
- Highly effective interpersonal skills and the ability to influence without direct authority
- A diligent problem solver with strong analytical skills
- Demonstrated record of success in executing critical deliverables independently
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