Proclinical is seeking a dedicated Senior Clinical Trial Manager (CTM) to join our global Clinical Operations Department. The successful candidate will play a crucial role in managing and executing clinical trials, ensuring compliance with regulations, maintaining timelines, and overseeing data collection and review. The Senior CTM will also be responsible for managing the Clinical Operations study team, Clinical Research Organizations (CROs), and third-party vendors.
Responsibilities:
- Lead day-to-day Clinical Operations activities for a clinical trial, including start-up, maintenance, and closure.
- Manage compliance and quality of a clinical trial, including maintaining accurate documentation of trial progress.
- Define and execute quality control steps, including study quality and performance metrics and reporting.
- Coordinate data review activities required of Clinical Operations team members.
- Contribute to the development of study protocols and understand study protocol objectives.
- Lead development of clinical trial-related documents, including approving and maintaining study plans.
- Conduct study feasibility and ensure proper site selection and setup.
- Manage and drive processes for outsourcing to CROs and other third-party vendors.
Key Skills and Requirements:
- Bachelor's degree in life sciences required; master's degree preferred.
- Relevant clinical operations experience with a focus on trial management.
- Excellent understanding and application of ICH/GCP guidelines.
- Strong interpersonal and communication skills.
- Ability to travel up to 25%.
- Proactive, organized, with attention to detail and excellent problem-solving skills.
If you are having difficulty in applying or if you have any questions, please contact Bo Forsen at b.forsen@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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