Clinical Data Manager

Responsibilities

• Lead end-to-end clinical data management activities for medical device studies across multiple therapeutic areas and all trial phases (I–IV)
• Design, build, and validate eCRFs and clinical databases using industry-standard EDC platforms (Medidata Rave, Oracle InForm, Veeva Vault, or similar)
• Develop and maintain key data management documents including DMPs, DVPs, edit check specifications, and data transfer agreements
• Perform ongoing data review, query management, and SAE reconciliation to ensure timely, high-quality data
• Collaborate with biostatistics, clinical operations, regulatory affairs, and medical monitors throughout the trial lifecycle
• Ensure all data management activities comply with FDA 21 CFR Part 11, ISO 14155, ICH E6(R2) GCP, MDR and applicable regulatory frameworks
• Support internal and sponsor audits; maintain inspection-ready TMF documentation
• Contribute to process improvement initiatives and SOP development

Qualifications & Personal Skills

• 5 years of clinical data management experience, with at least 2 years in medical devices
• Hands-on proficiency with one or more EDC/CDMS platforms (Medidata Rave, Oracle InForm, Veeva Vault, or equivalent)
• Solid working knowledge of FDA 21 CFR Part 11, ISO 14155, and ICH GCP E6(R2)
• Experience managing data across multiple concurrent studies and therapeutic areas
• Strong understanding of CDISC standards (CDASH, SDTM) is a plus
• Exceptional attention to detail and a systematic approach to problem-solving
• Excellent written and verbal communication skills; comfortable interfacing with sponsors and cross-functional teams
• Bachelor's degree in a life sciences, health informatics, or related field (Master's a plus)