Clinical Scientist, Clinical Development
New
O
Oruka TherapeuticsBiotechnology
Hybrid – Waltham, MA. Candidates will be required to be in-office in 3 days/week. Remote considered.Full-TimeMiddle
Salary140,000 - 155,000 USD per year
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Job Details
- Experience
- 3 years experience
- Required Skills
- Data AnalysisGCP
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.
- 3 years of relevant experience.
Responsibilities
- 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).
- 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.
- Conducts literature reviews as needed for focused scientific questions or documentation.
- Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams.
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