Clinical Trials Expert
4 days ago
Bristol Myers Squibb is a leading pharmaceutical company committed to driving innovation in clinical trials. We are seeking a highly skilled Scientific Project Lead to join our team in Early Clinical Development.
About the Role:
- We are responsible for implementing all facets of early clinical studies, including clinical trial design, execution, and monitoring.
- This role supports the Immunology, Cardiovascular, Fibrosis, and Neuroscience teams in developing and executing clinical trials that meet regulatory requirements.
- The ideal candidate will have excellent project management skills, be able to effectively communicate with cross-functional teams, and possess a strong sense of leadership and collaboration.
Key Responsibilities:
- Maintain a thorough understanding of assigned protocols and protocol requirements.
- Plan and lead the implementation of clinical study startup/conduct/close-out activities.
- Evaluate innovative trial designs in collaboration with the study physician.
- Manage protocol and ICF development process (e.g., documents and amendments).
- Serve as primary contact for site-facing activities such as training and support for clinical questions.
- Conduct and oversee activities related to data generation and validation.
- Develop clinical narrative plan and review clinical narratives.
- Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
- Review/develop site and CRA training materials and presentation at SIV and Investigator meetings.
- Author/review clinical study reports (CSRs) and clinical portions of Regulatory Documents.
- Collaborate and serve as primary liaison between external partners for scientific advice.
- Author/review abstracts, presentations, and manuscripts for external publications.
Requirements:
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).
- 1+ years experience in clinical science and clinical research.
- Proficient hands-on knowledge and experience in clinical development process.
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
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