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.)
Biotechnology Research and Pharmaceutical Manufacturing
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