Senior Clinical Trial Manager
Company: SciPro Agency
- Location: United States
- Seniority: Senior
- Employment type: Contract
- Posted: Yesterday
- Offer language: English
Job description
We are seeking an experienced Senior Clinical Trial Manager to lead clinical trial execution within a fast-paced biotech environment. The ideal candidate will have strong clinical operations experience, particularly in oncology, and a proven ability to manage studies from startup through closeout.
Key Responsibilities
- Lead clinical trial execution, ensuring timelines, budgets, and regulatory compliance.
- Oversee CROs, vendors, study budgets, and clinical trial deliverables.
- Manage site startup, enrollment, monitoring, and study closeout.
- Collaborate cross-functionally with Clinical, Medical, Regulatory, and Data Management teams.
- Identify study risks and implement mitigation strategies.
- Ensure TMF quality, inspection readiness, and ICH-GCP compliance.
Qualifications
- Bachelor's degree in Life Sciences or related field.
- 7+ years of clinical operations experience within biotech or pharma.
- Oncology clinical trial experience strongly preferred.
- Experience managing CROs, vendors, and global clinical studies.
- Strong knowledge of FDA regulations and ICH-GCP guidelines.
- Excellent leadership, communication, and organizational skills.
- Willingness to travel up to 25%.
