Clinical Data Management Specialist

• Design, develop, and maintain Case Report Forms (CRFs) and Data Management Plans (DMPs)
• Manage clinical trial data from study start-up through database lock, including CRF tracking, query resolution, and database maintenance
• Ensure accurate and timely entry, review, and cleaning of clinical data in accordance with Good Clinical Data Management Practices (GCDMP)
• Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs
• Lead data review meetings and provide input on data issues, discrepancies, and risks
• Develop edit checks and validation rules for Electronic Data Capture (EDC) systems
• Coordinate with external vendors for data transfers, reconciliations (e.g., lab, imaging), and system integrations
• Participate in audits and inspections to ensure compliance with SOPs, GCP, and regulatory guidelines (FDA, EMA, ICH)
• Generate and maintain documentation including Data Review Reports, Data Transfer Specifications, and Metrics Reports
• Support the development and implementation of CDM standard operating procedures and tools

Qualifications

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, or a related field
• 25 years of experience in Clinical Data Management within a pharmaceutical, biotech, or CRO setting
• Proficiency with EDC platforms (e.g., Medidata Rave, Oracle InForm, Veeva CDMS)
• Strong understanding of GCDMP, ICH-GCP, and regulatory requirements
• Excellent analytical, problem-solving, and organizational skills
• Effective written and verbal communication abilities
• Experience with coding dictionaries (MedDRA, WHODrug) is a plus
• Familiarity with SAS or other statistical tools is an advantage