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Director of Clinical Operations
2 months ago
**Job Summary:**
We are seeking an experienced Associate Director of Clinical Operations to lead the planning, execution, and conduct of complex clinical programs at Progenics Pharmaceutical Inc. The successful candidate will be responsible for managing all aspects of multiple clinical trials, with a focus on vendor and internal team management, to drive a high-functioning and results-driven team.
Key Responsibilities:
- Study Management: Oversee CRO and/or vendor activities, coordinate cross-functional department activities, and ensure successful achievement of milestones and quality deliverables in study management, including site selection, study start-up, recruitment, study conduct, and database lock and study close-out.
- Risk Management: Continuously assess risks to study performance, timelines, budgets, and proactively plan risk mitigation strategies.
- Quality Assurance: Lead quality reviews of study conduct, including TMF and monitoring report reviews, and lead inspection readiness activities for both internal sponsor audits and health agency audits (FDA, Health Canada, etc).
- Team Leadership: Direct or indirect management and oversight of CTA and/or junior COLs, and contribute to management decisions on project team resourcing needs and strategy.
- Operational Efficiency: Perform ongoing assessment of operational efficiency and communication, and adjust study processes to ensure high team performance.
Requirements:
- Experience: Minimum of 10 years of clinical research experience, with minimum of 6 years trial management experience in industry (sponsor or CRO), and at least 5 years of vendor management experience.
- Education: Masters' degree (MBA, MS or MPH) or PMP certification.
- Skills: Strong understanding of clinical trial methodology, drug development process, ICH-GCP guidelines, and applicable regulatory requirements, as well as experience in clinical program management and clinical operations management of clinical trials.
- Software Proficiency: Highly proficient in MS Office applications.
