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.
About the role
- 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.
Responsibilities
- Design and implement operational strategies, study management plans, and supporting documentation to drive study efficiency and quality (most complex studies).
- Continuously assess and improve clinical operations processes.
- Lead cross-functional study teams, coordinate with functional area representatives, and ensure timely execution of all study-related activities.
- Foster collaboration among internal and external stakeholders (including vendors, investigators, and regulatory authorities).
- Coordinate budgets and key performance metrics, including study start-up, enrollment, and data collection timeliness/quality.
- Plan, manage, and execute our most complex global clinical studies from protocol development through to Clinical Study Report (CSR) completion and Trial Master File (TMF) archiving.
Requirements
- At minimum, bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
- A minimum of 12 years’ relevant clinical research (or related) experience within the pharmaceutical industry.
- Previous experience in leading and managing a team of professional staff.
- A 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
- Professional development opportunities
Job title
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Degree requirement
Tech skills
Location requirements
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