Clinical Trials Manager
6 days ago
We are seeking an experienced Clinical Trial Manager to oversee the successful execution of our clinical studies. The ideal candidate will have a strong background in clinical operations, Good Clinical Practice (GCP), and FDA regulatory requirements.
Key Responsibilities:- Manage Contract Research Organizations (CROs) and ensure the successful execution of clinical studies
- Oversee the selection and management of external resources, including vendors and CROs
- Develop and implement clinical trial strategies to meet business objectives
- Collaborate with cross-functional teams to ensure seamless execution of clinical trials
- Ensure compliance with FDA regulations, ICH Guidelines, and GCPs
- BS or MS degree in a relevant field, such as life sciences or healthcare
- 5+ years of experience in clinical operations, preferably in the pharmaceutical or biotech industry
- Strong working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Experience in managing CROs and vendors, as well as developing and implementing clinical trial strategies
- Excellent written and verbal communication skills, with the ability to collaborate with cross-functional teams
- Able to travel up to 25% of the time
- Clinical trial management, oncology, drug development, ICH Guidelines, FDA Regulations, GCP, CRO, vendor management, travel
Bayside Solutions, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion.
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