Regional Vice President of Clinical Operations overseeing dialysis business at Fresenius Medical Care. Directing customer service, quality care, financial performance, and operational efficiency.
About the role
- 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.
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.
- Provide early input in CDP and study outline.
- Lead cross-functional study teams, coordinate with functional area representatives, and ensure timely execution of all study-related activities.
- Responsible for vendor selection/management/oversight, issue escalation, and inspection readiness.
- Act as the primary point of contact for all study-related matters, build and maintain strong relationships, mentor and support team members, and represent the study team in communications with senior management.
- Forecast, manage, and report on study 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.
- Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
- 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
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
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