Oncology Study Director
1 day ago
Key Responsibilities
- Participate in the planning, implementing, and managing of clinical trials in compliance with industry regulations and ICH-GCP.
- Oversight of CROs and clinical trial sites, ensuring timely delivery, meeting recruitment targets, and producing high-quality data.
- Review CRA monitoring reports to ensure protocol and operational compliance; escalate issues for resolution.
- Collaboration with teams for efficient study start-up, identifying risks and ensuring timelines are met.
- Act as a subject matter expert on assigned protocols and manage CRO/site during start-up activities, including contract negotiations and document collection.
Requirements
- Minimum of 5 years of clinical operational experience in biotechnology, pharmaceuticals, and CROs.
- Strong understanding of GCP, ICH, GDP, and relevant CFRs; familiarity with MHRA, EMA, and international regulations is a plus.
- Experience with clinical trial site start-up and initiation.
- Proven ability to build and maintain relationships with clinical trial sites and Principal Investigators.
- Strong communication skills for coordinating activities with internal teams, sites, and vendors.
- Proactive in identifying project challenges and proposing corrective actions with minimal supervision.
- Capable of working independently and delivering high-level presentations.
Salary Information
$120,000 - $150,000 per year.
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