Senior Clinical Data Manager
Brief Position Summary:
The Senior Clinical Data Manager provides expertise in all data management activities related to the preparation and implementation of clinical trials in the US and internationally.
Works closely with Biostatistics & Programming, Clinical Operations, Safety, Regulatory, and other related disciplines to support database development and reporting for all clinical studies.
Primary Position Responsibilities/Tasks:
• Provide oversight/management (of CRO's) and participate in study set-up and initiation procedures such as eCRF design, database design, edit check design/review, and DMP (data management plan) review.
• Ensure the proper collection, management, and storage of clinical trial data (according to regulatory requirements).
• Ensure proper clinical data review and query management.
• Assist in developing data management guidelines and quality processes to ensure final databases are accurate.
• Perform data validation and quality checks, and initiates corrective and preventive actions as indicated.
• Run standard and custom reports (in Medidata Rave) to support Clinical Operations and Development.
• Assign levels of access, and provide training for team members in use of Medidata Rave system.
• Participate in other activities and meetings to support Biostatistics, Clinical Operations, and the Development Team as needed.
• Bachelor’s degree in medical, scientific, biological, statistical, computer science, or related field.
• Five years of clinical trial data management in the pharma/biotech industry.
• Experience in clinical trials through Phase 3 (NDA submission).
• Data management experience using Medidata Rave EDC system.
• Proficiency with Microsoft Office (Excel, Word, PowerPoint, and Outlook).
• Experience in the design and management of clinical trial databases using Medidata Rave, as well as reporting capabilities.
• Familiarity with ICH GCP as well as general knowledge of industry practices and standards such as CDISC-SDTM data standardization specifications.
• Ability to anticipate and timely escalate issues and to define appropriate action plans.
• Strong vendor management skills.
• Experience working with safety data and coding dictionaries (MedDRA and WHODRL).
• Custom report-writer (Medidata BOXI) experience.
• Experience setting up and/or utilizing standardized “global library” for CRFs.