Director Clinical Operations Lead overseeing operational strategies for global clinical studies at CSL Behring. Ensuring efficient execution, budget management, and stakeholder collaboration for complex research initiatives.
About the role
- Associate Director Clinical Operations Lead responsible for operational strategies and study management in biopharmaceuticals. Leading complex clinical studies and cross-functional teams to ensure successful project delivery.
Responsibilities
- Design and implement operational strategies, study management plans, and supporting documentation to drive study efficiency and quality
- Lead cross-functional study teams, coordinate with functional area representatives, and ensure timely execution of all study-related activities
- Act as the primary point of contact for all study-related matters, build and maintain strong relationships, mentor and support team members
- Forecast, manage, and report on study budgets and key performance metrics
- Plan, manage, and execute more complex global clinical studies from protocol development through to Clinical Study Report (CSR) completion
Requirements
- Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
- Minimum of 10 years’ relevant clinical research (or related) experience within the pharmaceutical industry
- Previous experience in leading and managing a team of professional staff
- Solid understanding of the drug development process and specifically, each step within the clinical trial process
- Experience in overseeing large and/or complex global clinical trials
- Robust budget forecasting and management experience
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
Benefits
- Health insurance
- 401(k) matching
- Professional development opportunities
- Flexible work arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Director Clinical Operations Lead driving operational strategy and study management for global clinical studies at CSL Behring. Collaborating with cross - functional teams to meet program goals within timelines and budget.
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