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Role & Responsibilities
• Support study setup including database design, CRF testing, and Data Validation Manual (DVM) creation
• Identify, review, and resolve data discrepancies and queries in EDC systems
• Review data listings, validation reports, and perform advanced data cleaning
• Perform SAE and third-party vendor reconciliations
• Act as subject-matter expert for study-specific data processes
• Train and mentor junior data-management staff
• Prepare project status reports for CDM leadership and clients
• Contribute to global process-improvement initiatives
• Liaise with global stakeholders and support cross-functional communications
Qualifications & Experience
• Bachelor’s degree or equivalent
• Minimum 3+ years of experience in clinical data management or related field
• Experience with EDC systems such as Medidata Rave and Veeva Vault
Skills
• Strong data review, query management, and reconciliation skills
• Excellent attention to detail and documentation practices (eTMF/GDP)
• Proficiency in MS Office and clinical trial data tools
• Strong analytical, communication, and stakeholder coordination abilities
• Knowledge of GCP, SOPs, WPDs, and clinical trial terminology
Preferred
• Experience working with global clinical data teams
• Familiarity with process improvement initiatives
About the Company
• Thermo Fisher Scientific is a global early-phase clinical research network delivering high-quality clinical data and innovative research solutions