Sr. Clinical Data Manager

Required

• Bachelor's or Master’s degree in Life Sciences, Data Science, Computer Science, or a related field.
• 7+ years of clinical data management experience, with at least 2 years in a senior or lead role.
• Experience with medical device trials or combination products (IDE, PMA, 510(k), CE marking, etc.).
• Strong understanding of EDC systems and data standards (CDASH, SDTM, CDISC).
• Knowledge of regulatory requirements (FDA, EMA, ISO 14155, GCP, GDPR).
• Excellent organizational, leadership, and communication skills.

• Lead, manage, execute end-to-end data management activities for clinical trials conducted inhouse or outsourced to CRO’s.
• Develop and maintain Data Management Plans (DMPs), CRFs, edit check specifications, and other essential documents.
• Oversee database build.
• Testing, validation, and UAT processes in EDC systems
• Ensure timely and high-quality data collection, cleaning, reconciliation, and database lock activities.
• Collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, QA, and external CROs/vendors. 
• Ensure data integrity and compliance with GCP, FDA, MDR/IVDR, and other applicable regulatory standards.
• Participate in and contribute to protocol development, case report form design, and data flow diagrams.
• Conduct and oversee data reconciliation, external data integrations (labs, imaging, etc.), and coding of medical terms (MedDRA, WHO-DD).
• Provide study specific reports and data listings on regular basis and for ad-hoc requests
• Support audit readiness and participate in regulatory inspections when required.
• Mentor junior team members and provide strategic input into department process improvements and SOP development.