Clinical Scientist, Clinical Development
About The Position
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. The Clinical Scientist collaborates closely with cross-functional teams to ensure the generation of high-quality clinical data. Additionally, they work closely with the Medical Director, Clinical Development to execute key tasks.
Requirements
- Advanced degree in life sciences, such as a PhD, PharmD or related field
- Understanding of clinical trial methodologies and regulatory requirements
- Experience in clinical study design, data analysis, data review and interpretation
- Good written and verbal communication skills
- Ability to work effectively in a collaborative, cross-functional environment
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 in 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.
- 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.
Benefits
- An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Professional, Scientific, and Technical Services
Education Level
Ph.D. or professional degree
Number of Employees
11-50 employees
