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Precision for Medicine is a Contract Research Organization (CRO) that integrates clinical trial execution with scientific expertise, laboratory capabilities, and advanced data sciences. The company is expanding in the Asia Pacific region and seeks a Senior Clinical Data Manager to lead clinical trial data management operations.
The Senior Clinical Data Manager will serve as the primary data management contact for assigned clinical projects, overseeing all aspects of the data management lifecycle from study startup through database lock. Key responsibilities include:
• Lead clinical data management for assigned projects, ensuring backup coverage, continuity, and timely task completion
• Oversee data entry processes, including development of guidelines, training, quality assurance, and resource allocation
• Develop Case Report Form (CRF) specifications from study protocols and coordinate stakeholder review
• Conduct database build User Acceptance Testing (UAT) and maintain quality-controlled documentation
• Specify and oversee edit check development (electronic and manual data review)
• Create and maintain comprehensive data management documentation for the Trial Master File
• Train clinical research personnel on study-specific systems and procedures
• Review and query clinical trial data according to Data Management Plans
• Perform medical coding and coordinate Serious Adverse Event/Adverse Event reconciliation
• Manage relationships with third-party vendors (EDC, data vendors) in a project management capacity
• Assist with SAS programming and quality control of data management programs
• Identify and troubleshoot operational issues using metrics data and audit reports
• Participate in SOP development and process documentation
• Attend strategy meetings, bid defenses, and client engagement meetings as needed
• Present software demonstrations and training sessions
Required qualifications: Bachelor's degree and/or equivalent related experience; 8+ years in clinical research data management; proficiency with clinical database management systems (Medidata Rave and Veeva required); strong knowledge of drug, device, and biologic development; excellent organizational, communication, and leadership skills; professional English proficiency (written and oral); ability to handle diverse clinical research tasks; occasional travel required.
Preferred qualifications: Clinical, scientific, or healthcare background; medical dictionary coding experience (MedDRA, WHODrug); CDISC standards knowledge (CDASH, SDTM, ADaM); oncology or orphan drug therapeutic experience.
