Senior Manager, Clinical Data Management

Role Summary

Senior Manager, Clinical Data Management. Reporting to the Head of Data Management, you will help lead clinical trials and develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures

Responsibilities

• Act as Data Management lead on assigned projects
• Provide CRO oversight and management as needed
• Review and approve the database design, edit checks, CRF completion guideline, and Data Management Plans drafted by CROs to ensure they are compatible with ensuring CDASH, SDTM and industry standards
• Work with DB programmers to design (e)CRFs and edit checks in the EDC system
• Develop test scripts and test data for User Acceptance Testing (UAT)
• Perform and document database and report UAT
• Receive, integrate, and reconcile electronic data
• Perform data review via listings and EDC system, issue and resolve queries
• Manage queries to ensure data completeness and integrity
• Review and work with Clinical team on medical coding listings
• Assist with data listing design for Sponsor data review
• Perform SAE reconciliation
• Perform pre-lock and data lock tasks
• Prepare training materials and user guides for EDC data collection tools
• Participate in client and team meetings as required
• Design, generate, and review status metric reports as needed
• Perform archiving of study databases and related documents
• Provide input to timelines to ensure timely completion of assigned tasks
• Provide regular status updates, keeping the team informed of any changes
• Organize and file study documentation
• Work with the team to implement technical solutions and resolve issues
• Additional duties and responsibilities as assigned

Must-Haves

• Bachelor‚Äôs Degree in a scientific or health related field or equivalent and 8+ years of clinical data management experience in biotech or pharma, with experience across EDC platforms, Medidata EDC preferred
• Experience in a clinical research environment, preferably in biotechnology and focused on Neurology and CNS indications; epilepsy, pain and mood disorders a plus
• Solid technical skills across data platforms; programming experience preferred
• leading a trial from a Data Management perspective
• Previous experience designing clinical trials utilizing CDASH and SDTM standard terminology
• Proficient in cross collaboration with other related functions such as Biostatistics, Statistical Programming, Clinical Operations and Pharmacovigilance
• Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data
• Proficient with data visualization software/tools
• Experience in regulatory GCP inspections/audits preferred
• Ability to manage multiple projects in a fast-paced environment
• Excellent communication and time management skills

Skills

• Data management leadership
• EDC systems (Medidata EDC preferred)
• CDASH/SDTM standards
• UAT testing
• Data reconciliation and query management
• Medical coding review
• Cross-functional collaboration

Education

• Bachelor‚Äôs Degree in science or health-related field or equivalent