Clinical Scientist, Clinical Development (Multiple openings)

The Clinical Scientist plays a key role in the execution and operational support of clinical trials, assisting in the collection and review of clinical data to ensure study success. This role involves supporting protocol development, study implementation, data review, and documentation preparation to align with clinical development goals.

Key Responsibilities:

• Clinical Trial Design and Oversight:
  • Contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods.
  • Monitors the data of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines.
  • Perform data review, reconciliation, and standardization to ensure high-quality outputs.
  • Reviews clinical data to support the assessment of the safety and efficacy of the investigational drug.
  • Supports the development of clinical documents required during the clinical development process (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports).
• Scientific Expertise:
  • Maintains knowledge of the therapeutic area, disease state, and potential drug effects.
  • Assesses clinical data to help identify and analyze safety concerns and adverse events. Stays current with relevant medical literature and clinical trial methodologies.
  • Conducts literature reviews as needed for focused scientific questions or documentation.
• Cross-Functional Collaboration:
  • Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical, and project management teams to ensure data integrity during the clinical development process.