- Supports the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
- Oversees the conduct of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines
- Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug
- Authors and contributes to clinical and non-clinical documents required during the clinical development process
- Provides medical expertise of the therapeutic area, disease state, and potential drug effects
- Reviews clinical data to identify and analyze safety concerns and adverse events, and makes appropriate recommendations to the team
- Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams to help ensure optimization of the clinical development process
- Contributes to the overall clinical development strategy
- Helps to identify critical clinical development milestones and helps the team to drive toward meeting or exceeding timelines
- Leads the clinical contribution for clinical study reports, clinical documents and regulatory submissions
Project ManagementGCP