Director – Clinical Operations Lead
CSL
full-time
Posted on:
Location Type: Hybrid
Location: King of Prussia • Pennsylvania • United States
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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.
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical operationsstudy managementbudget forecastingdata collectionprotocol developmentClinical Study Report (CSR)Trial Master File (TMF)vendor managementperformance metricsclinical trial process
Soft skills
leadershipcommunicationmentoringrelationship buildingteam coordinationproblem solvingorganizational skillscross-functional collaborationissue escalationsupporting team members
Certifications
bachelor’s degreeRN diplomacertified medical technologist