Director, Clinical Operations Lead
CSL
full-time
Posted on:
Location Type: Hybrid
Location: Maidenhead • United Kingdom
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Job Level
Tech Stack
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchclinical trial managementbudget forecastingdata collectionprotocol developmentClinical Study Report (CSR)Trial Master File (TMF) archivingstudy efficiencyperformance metricsdrug development process
Soft skills
leadershipcollaborationcommunicationteam managementorganizational skillsstakeholder engagementproblem-solvingcross-functional coordinationstrategic planningprocess improvement