Lead Clinical Data Manager

At CooperVision, a division of CooperCompanies, we’re driven by a unifying purpose to help people to experience life’s beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges – including astigmatism, presbyopia, and childhood myopia. We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers. Learn more at www.coopervision.com.

Job Summary:

Leads all aspects of clinical data management activities from study initiation through database lock and study closeout. Develops, optimizes and controls data management system, including external clinical research centers in compliance with medical device regulations. Oversees and ensure that all CooperVision sponsored clinical trial data are accurate, complete, and compliant.

• Generate, contribute, and/or review key study documentation such as data management plans, case report forms (CRFs), database specifications, test plans for user acceptance testing (UAT), and data transfer specification and agreements
• Lead electronic case report form (eCRF) developments and facilitate cross-functional reviews of eCRF content
• Support the design, development, and validation of clinical trial databases and eCRFs, including edit checks within the Electronic Data Capture (EDC) system
• Perform training on the EDC system, dataflow, and quality control (QC) processes to personnel as appropriate
• Perform and/or oversee data cleaning, issue queries, query resolution, and delivery of high-quality datasets to support trial milestones and regulatory submissions; assist Clinical Operations, Biostatistics, Statistical Programming, Investigational sites, and/or Clinical Research Organization with resolving queries
• Perform third party non-Case Report Form data management activities 
• Ensure delivery of datasets, annotated CRFs, and related materials in the appropriate formats
• Participate in the preparation, review, and validation of submission-ready datasets for regulatory filings (e.g., FDA, EU MDR, PMDA, NMPA).
• Lead efforts in developing and maintaining standard database validation checks for common modules as well as for indication or research objective specific modules
• Ensure that documentation and data records, including archiving, meet regulatory and inspection standards
• Ensure compliance with industry standards and regulations (ISO, FDA, EU MDR) and assist in audit and inspection readiness
• Champion and assist the effective utilization of AI tools to enable automation, continuous process improvements, technology modernization, and efficiency initiatives.
• Serve as the main liaison for vendors or partners handling data deliverables, clarifying expectations and maintaining streamlined communication between internal and external teams
• Develop and/or modify standard operating procedures (SOPs) for clinical data management to comply with industry standards and regulations
• Establish and manage data quality standards, ensuring adherence to internal procedures and external guidelines
• Perform importing and reconciling external datasets, maintaining consistency across all study databases
• Track and communicate progress metrics, risks, and outcomes to senior management
• Coordinate closely with functional leads in Clinical Research, Clinical Operations, Biostatistics, Safety, and/or Regulatory Affairs to ensure seamless data flow and reporting

Travel Requirements: 
Minimal travel (5%) required, occasionally to research centers to establish or improve data management procedures. 
 

Knowledge, Skills and Abilities:

• Bachelor’s degree in life science, computer science or closely related discipline plus minimum of 8 years of experience in Clinical Data Management, or 
• Master of Science in life science, computer science or closely related discipline plus minimum of 5 years of experience in Clinical Data Management