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Oncology Clinical Trials Supervisor
2 months ago
As a key member of the Oncology Clinical Operations team, the Clinical Trials Supervisor will play a vital role in managing and overseeing clinical studies focused on oncology. This position requires a highly skilled and motivated individual who is dedicated to advancing clinical research and improving patient outcomes.
Key Responsibilities:
1. **Document Management:**
- Draft and facilitate the review of essential documents such as study protocols, informed consent forms, case report forms, monitoring plans, and clinical study reports.
2. **Protocol Interpretation:**
- Effectively understand, interpret, and communicate protocol requirements to team members and stakeholders.
3. **Timeline Management:**
- Ensure that study timelines are maintained and adhered to throughout the clinical trial process.
4. **Data Review Coordination:**
- Coordinate the review of data listings and assist in the preparation of interim and final clinical study reports.
5. **Project Support:**
- Assist in identifying activities that align with project priorities within the functional area.
6. **Vendor Collaboration:**
- Contribute to the development of Requests for Proposals (RFPs) and participate in the selection process of Contract Research Organizations (CROs) and vendors.
7. **Training and Development:**
- Provide training to CROs, vendors, investigators, and study coordinators regarding study requirements.
8. **Budget Development:**
- Assist in the formulation of study budgets and ensure financial oversight.
9. **Mentorship:**
- Participate in the recruitment and development of Clinical Trials Management Associates and support their professional growth.
10. **Scientific Contributions:**
- May contribute to the creation of abstracts, presentations, and manuscripts, and assist in designing scientific communications.
Qualifications:
- A minimum of 5 years of relevant experience with a Bachelor’s degree in a scientific discipline.
- At least 3 years of experience with a Master’s degree or higher in a scientific field is preferred.
- Proven experience in managing oncology clinical trials.
Skills:
- Strong teamwork, communication, decision-making, and organizational abilities are essential.
- In-depth knowledge of FDA and/or EMA regulations, ICH guidelines, and GCP standards governing clinical studies.
- Proficiency in Microsoft Word, PowerPoint, and Excel.
Why Join Us:
At Gilead Sciences, we are committed to creating a healthier world. Our mission to tackle significant health challenges requires collaboration, determination, and a relentless drive to make a difference. Join our team and contribute to the discovery and development of life-changing scientific innovations.