• Responsible for the oversight of data management CRO activities supporting Cara Therapeutics clinical programs from database start-up through database lock and CSR/submission.
• Serves as primary point of contact with the DM CROs, 3rd party vendors and internal study teams.
• Works with internal team and DM CRO to develop study timelines and ensures all DM related deliverables are met.
• Oversees the development of the clinical database (DB), including user requirements, edit rules/checks, query logic and data validation.
• Oversees the development of key data management documents such as case report forms (CRF), data validation specifications, manual data review guidelines, programable edit checks, and Data Management Plans DMP) Ensures compliance with these study documents.
• Participates in the review of Clinical research documents (e.g. Protocols, Safety Monitoring Plans, Communication Plans).
• Works with the CRO to ensure the clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock.
• Organizes study specific meetings (e.g. Protocol Deviation review, Medical Data review).
• Develops, tracks, analyze and report, as applicable, on data management performance metrics.
• Assist/participate in the preparation and oversight of study audits/inspections both internal and external.
• Develop and/or revise Data Management SOPs, Work Instructions and templates/standards incorporating the industry’s best practices and any applicable Regulatory guidelines and requirements.
• Bachelor’s degree in a science related field and/or computer systems/IT background.