Senior Clinical Trial Manager
New
D
Disc MedicineBiopharmaceutical
United StatesFull-TimeSenior
Salary151,000 - 185,000 USD per year
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Job Details
- Experience
- 7+ years
- Required Skills
- GCPMicrosoft Office
Requirements
- BA/BS degree required.
- 7+ years of applicable clinical trial experience required.
- 5+ years of vendor and CRO management experience required.
- Experience with Phase III oncology studies required.
- Thorough knowledge of FDA, EMA, and ICH GCP guidelines required.
- Advanced skills in Microsoft Office programs.
- Working knowledge of electronic data systems.
- Strong interpersonal and organizational skills.
- Must be willing to travel both domestically and internationally.
- Experience working on project teams.
- Strong business acumen with knowledge of multidisciplinary functions like data management, biostatistics, and regulatory.
Responsibilities
- Support the overall management of global clinical trials, including planning, execution, and closeout.
- Evaluate, select, and oversee CROs, external vendors, and consultants to ensure trial execution.
- Contribute to the drafting and review of clinical documents like protocols, informed consent forms, and investigator brochures.
- Ensure trial documentation and the Trial Master File remain in audit-ready condition.
- Review clinical monitoring visit reports and ensure follow-up items are resolved.
- Identify risks and implement proactive mitigation strategies.
- Liaise with clinical site staff and Investigators to maintain effective sponsor-site relationships.
- Monitor progress of clinical study activities, budgets, and timelines.
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