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.)
