Clinical Scientist, Clinical Development
New
O
Oruka TherapeuticsBiotechnology
Remote or Hybrid if commutable to office in Waltham, MAFull-TimeMiddle
Salary$146,000 to $161,000
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Job Details
- Experience
- 3 years experience
- Required Skills
- Data Analysis
Requirements
- Advanced degree in life sciences (PhD, PharmD, or equivalent).
- Minimum 3 years of relevant experience.
- Deep understanding of clinical trial methodologies.
- Knowledge of regulatory requirements in clinical development.
- Proven experience in clinical study design.
- Experience in data analysis, review, and interpretation.
- Strong written and verbal communication skills.
- Demonstrated ability to work effectively in a collaborative, cross-functional environment.
Responsibilities
- Contribute to the development of clinical trial protocols, patient selection criteria, and study endpoints.
- Monitor clinical trial data at study sites to ensure adherence to protocols and GCP guidelines.
- Perform data review, reconciliation, and standardization to maintain high-quality outputs.
- Review clinical data to support the assessment of safety and efficacy of investigational drugs.
- Support the development of clinical documentation, including Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports.
- Conduct literature reviews to address focused scientific questions.
- Collaborate cross-functionally with clinical operations, regulatory, medical affairs, biometrics, and project management teams.
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