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gcp sap biostatistics protocols crfs๐ Description
- Support clinical aspects of studies and work with cross-functional teams.
- 12-month contract, renewable; 20-30 hours per week with flexible hours.
- Deliverables: screening enrollment, site inquiries, data review/cleaning, CRFs and SAP.
- Develop responses to Health Authorities and IRBs with other functions.
- Perform duties per company values, policies, and regulatory requirements.
- Meet deadlines in a fast-paced environment with a collaborative, solutions-focused approach.
๐ฏ Requirements
- Undergraduate degree required; advanced health science degree preferred.
- 10+ years biotech/pharma clinical science experience.
- Experience in oncology trials; early development a plus.
- Ability to evaluate, interpret, and present complex data.
- Knowledge of biostatistics, GCP, and regulatory requirements.
- Strong verbal and written communication and presentation skills.
- Flexible, responsive, and self-sufficient.
- Capable of meeting deadlines in a fast-paced, collaborative environment.
๐ Benefits
- Paid Time Off, Holidays, and Sick Leave.
- Medical, Dental, and Vision plans.
- Short- and Long-Term Disability.
- Life/AD&D coverage; Flexible Spending Accounts.
- Pet Insurance and Employee Assistance Program.
- 401(k) with Erasca contribution and ESPP option.
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