Career Category Clinical Development Job Description In this vital role you are accountable for the management and oversight of data collected within a study/program, you will lead end-to-end data management and ensure high-quality, timely, and decision-ready data that enables successful clinical trial delivery.
• Serve as the single accountable leader for study-level data management, driving quality, delivery, and cross-functional alignment, locally and globally
• Lead development and execution of the Data Management Plan and Integrated Data Review Plan (IDRP) aligned to protocol and program strategy
• Drive database build, UAT, and go-live readiness in partnership with Database Design and Acquisition teams
• Oversee study conduct activities including data cleaning, query management, reconciliation, and database lock preparation, ensuring we are ‘delivery ready’ at all times
• Monitor study data metrics (e.g., eCRF entry, Non-CRF data collection, query aging, reconciliation backlog, KRIs) and proactively resolve issues to ensure on-time delivery
• Lead data deliverables, proactive in follow up, ensuring issue resolution and high-quality outputs
Basic Qualifications:
• Doctorate Degree OR
• Master’s Degree and 2 years of life science, computer sciences, business administration experience OR
• Bachelor’s degree and 4 years of life science, computer science, business administration experience OR
• Associate’s degree and 8 years of life science, computer science, business administration experience OR
• High school diploma / GED and 10 years of life science, computer science, business administration experience
Preferred Qualifications:
• 5 years’ work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
• Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
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