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Clinical Trials Lead
3 weeks ago
We are seeking a skilled professional to oversee the successful execution of investigator-initiated trials from start-up to close-out. This role will involve managing multi-site trials, ensuring compliance with regulatory requirements and institutional SOPs.
Key Responsibilities:
- Project manage multi-site clinical trials, monitoring progress and ensuring timely completion within scope.
- Develop and maintain trial master files, including reviewing and approving trial documentation.
- Liaise with vendors and stakeholders to ensure smooth trial operations, including contracting and issue resolution.
- Review and maintain clinical trial documentation, including ISFs and participant binders, to ensure adherence to ALCOA principles and trial protocol.
- Perform quality checks on site clinical trial documentation, identifying areas for improvement and implementing corrective actions.
- Bachelor's degree in life science, biomedical sciences or related field.
- At least 4 years of experience in clinical trials management, including minimum 1 year of CRA experience.
- Meticulous attention to detail, strong organizational skills and ability to handle multiple priorities independently.
- Excellent communication and interpersonal skills, with ability to work effectively with cross-functional teams.
- Opportunity to work on complex clinical trials projects.
- Professional growth and development opportunities.
- A collaborative and dynamic work environment.
- This is a full-time position, working closely with a team of professionals.
- Travel may be required to conduct site visits and attend meetings.