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Role Description

ClinChoice is searching for a Senior Clinical Data Manager Consultant to join one of our clients. This role will be providing general DM support role tasks, including:

• Perform EDC (electronic data capture system) build validation and update supporting documentation, including but not limited to:
  • eCRF design specification
  • Edit check documents
  • UAT test/issue logs
  • UAT summary report
• Assist oversight of EDC users and other Clinical databases user access management, including:
  • Compiling master user lists
  • Reviewing appropriate activating/deactivating user accounts
• Accountable for on-time and comprehensive review of clinical study data listings
• Oversees and/or performs the reconciliation of key data points collected in EDC with other sources such as the Safety Database and Third Party/External Data Vendor systems
• Support the design and testing of technical CDM components including eCRFs, Edit Checks, reports, and listings
• Manages the effective communication of data issues and discrepancies to study sites via the query management process
• Escalates relevant issues to lead data manager and appropriate study team as needed to facilitate timely resolution
• Investigates and analyzes possible solutions using experience, judgment, and precedent
• Experience managing study-level data management activities and working with external vendors
• Familiarity with clinical data systems (e.g., Medidata RAVE, Oracle Clinical, Veeva) and industry data standards (e.g., CDISC, SDTM)

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Computer Science, or a related field
• 5+ years of experience in clinical data management
• Experience in Cardiovascular required
• Strong knowledge of clinical trial processes and regulatory requirements
• Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault, etc.)
• Excellent communication, problem-solving, and leadership skills

Company Description

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity.