Data Management Lead at Astellas Pharma. This role focuses on study‑level data management activities within a drug development program, including deliverables such as data standards, eSource, medical coding, database build, external data, central monitoring, and vendor oversight. The Data Management Lead ensures projects are executed on time and meet global standards, providing expert guidance to the clinical program team and leading process improvement initiatives.
Key Activities
* Very strong subject matter expertise in Data Management, supporting multiple studies concurrently with minimal oversight.
* May act as a functional DM expert for a specific specialty area such as data standards, medical coding, eSource, external data, data visualization, and analytics.
* Review Key Risk Indicators (KRIs) across sites, regions, and countries, and support root‑cause analysis of operational and patient data observations.
* Perform vendor oversight activities across multiple studies, review vendor processes, and provide suggestions for improvement using metrics and KPIs.
* Document process deviations and communicate to functional managers, taking immediate action when quality concerns arise.
* Lead data review meetings with Medical, Clinical Operations, Biostatistics, and Programming teams to discuss deviations and protocol‑relevant data values.
* Apply strong regulatory knowledge (e.g., GCP) to data management activities and output quality.
Essential Knowledge & Experience
* Substantial experience in pharmaceutical/clinical research or health services, with progressive leadership responsibility in Data Management.
* Demonstrated expertise from program inception through regulatory submission (regulatory submissions preferred).
* Leadership and subject‑matter expertise in global Data Management process improvement initiatives.
* Extensive experience with external data management and digital health solutions (e.g., eSource, eCOA, eConsent) and risk‑based quality management principles.
* Advanced understanding of clinical data standards (e.g., CDISC) and ability to apply them across studies and programs.
* Prior inspection and audit experience.
Preferred Qualification
* SCM Certified Clinical Data Manager (CCDM) preferred.
* Experience with RAVE, eClinical Solutions, Elluminate, and CluePoints is a plus.
* Bachelor’s degree in biological science, health‑related, computer science, or equivalent experience.
Additional Information
The position is permanent and based in our Global Capability Centre in Warsaw, Poland, with a hybrid working model that requires some office presence. Candidates must be located within a commutable distance of the office.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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