Clinical Data Manager / Data Quality Leader Location: Hybrid – 3 days onsite / 2 days work from home About the Role We are seeking an experienced Data Manager / Data Quality Leader to support Medical Affairs and Evidence Generation initiatives within a regulated pharmaceutical/biotech environment. This role will focus on clinical data lifecycle management, data quality oversight, vendor coordination, and implementation of scalable data solutions aligned with FAIR data principles (Findable, Accessible, Interoperable, Reusable). The ideal candidate will bring strong expertise in clinical data management, regulatory compliance, data review, and cross‑functional collaboration while ensuring high‑quality and inspection‑ready clinical datasets. Key Responsibilities Oversee collection, review, validation, and management of clinical and external study data Develop, maintain, and oversee clinical databases and data management processes Ensure data quality, consistency, and compliance with regulatory requirements and industry standards Perform aggregate data reviews using visualizations, trend analysis, and data surveillance techniques to identify anomalies and risks Collaborate with cross‑functional teams including Clinical Operations, Biometrics, Medical Affairs, and external vendors Provide oversight of CROs, FSPs, and external data vendors to ensure timely and high‑quality deliverables Support audits, inspections, and regulatory submissions related to clinical data Partner with stakeholders to implement fit‑for‑purpose data solutions and support FAIR data principles Assist with data transfer agreements, external data integrations, and standardized data models Support study startup, conduct, closeout, and database lock activities across multiple studies Required Qualifications BS or MS in Life Sciences, Bioinformatics, Data Science, Computer Science, or related discipline 5–10 years of Clinical Data Management experience within pharma, biotech, or CRO environments Strong understanding of GCP / ICH‑GCP guidelines Strong understanding of clinical data management processes Strong understanding of CDISC standards (SDTM/CDASH preferred) Strong understanding of regulatory and compliance requirements Experience overseeing CROs, FSPs, and/or external vendors Strong problem‑solving, organizational, and communication skills Ability to manage multiple priorities in a fast‑paced environment Preferred Qualifications Familiarity with EDC systems Experience with Real World Data (RWD), biomarker, or external datasets Experience with data visualization and analytics tools Programming knowledge in SAS, SQL, Python, or R Experience with MedDRA and WHODrug standards Exposure to FAIR data principles and enterprise data systems What We’re Looking For Strong leadership and stakeholder management skills Strategic and solution‑oriented mindset Ability to work independently with minimal oversight Strong collaboration and communication abilities Passion for improving data quality and advancing healthcare research #J-18808-Ljbffr
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