Director of Clinical Study Management, Oncology & Global Trials
Overview
Lead inhouse clinical study management for oncology programs across global sites. Own study delivery, timelines, quality, and vendor oversight to ensure inspection-ready trials. Collaborate across CR&D, QA, Regulatory, and Finance to optimize performance and drive high-impact patient outcomes. This role blends strategic leadership with hands-on operational execution in a matrix organization.
What You'll Do10
- 1Build and lead inhouse clinical operations study management teams responsible for delivery of assigned clinical studies
- 2Manage clinical study management personnel across assigned clinical studies to ensure timely, high-quality delivery
- 3Ensure compliance, quality and timeline objectives are met for all assigned studies
- 4Collaborate with internal stakeholders to deliver trial objectives on time, on budget, and with high quality
- 5Accelerate enrollment and drive high quality by working with CR&D FA leads as appropriate
- 6Own assigned clinical trial audits and partner with Clinical Quality Assurance
- 7Represent Clinical Study Management in process workstreams and initiatives
- 8Solve problems using judgment on regulations, guidelines, investigator interactions, and timelines
- 9Manage resources to ensure appropriately skilled staff are assigned for portfolio execution
- 10Develop, coach and retain top talent in the clinical program team and set clear performance standards
Requirements10
- 112+ years of relevant experience with a Bachelor`s degree or 10+ years with a Master`s Degree in clinical study management within biotechnology, pharmaceutical, or healthcare industry
- 2Experience managing international oncology clinical studies and programs
- 3Proven track record delivering clinical trials supporting global regulatory submissions and product approvals
- 4Management experience in a clinical trial setting with cross-functional collaboration in a matrix organization
- 5Demonstrated leadership, problem solving, and ability to work in a fast-paced team environment
- 6Budget, resource, headcount, process, productivity, quality and project delivery management expertise
- 7Comprehensive understanding of ICH GCP and Global/Regional/Local regulatory requirements
- 8Strong communication skills in English, both written and spoken
- 9Strategic thinking and high emotional intelligence with a process improvement mindset
- 10Leadership that attracts, motivates, develops and retains talent and aligns with company mission
Salary Insight
$203 - $221k per year
Location
Required Skills
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