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Actalentposted 6 months ago
Full-time • Mid Level
Onsite • Alameda, CA
10,001+ employees
Administrative and Support Services
About the position
The Clinical Scientist role at Actalent involves key responsibilities in reviewing scientific data, developing product knowledge, and collaborating with various stakeholders to ensure the success of clinical studies. This fully remote position emphasizes data review, protocol development, and regulatory documentation, contributing to the overall drug development process.
Responsibilities
- Develop and review various study protocols with minimal guidance.
- Prepare and present reports and presentations on clinical research findings.
- Regularly review information to check safety procedures and data accuracy.
- Review and validate clinical study reports (CSRs).
- Contribute to, coordinate, and review regulatory documents and Consent Forms (ICF).
- Collaborate with study team members including Clinical/Medical Affairs and Regulatory Affairs.
- Meet deadlines and milestones based on assigned study goals.
- Participate in protocol design and implementation to meet regulatory requirements.
Requirements
- 5 years of data review experience.
- 3+ years of data review in oncology.
- Experience with TFL Review.
- Medical Safety Data Review expertise.
- Results evaluation/review experience.
- Completed Master's degree or higher.
