Oruka Therapeutics

Manager

• Responsible for the oversight of all data management CRO activities supporting Oruka Therapeutics, Inc clinical programs from database start-up through database lock and CSR/submission.
• Primary point of contact with the DM CROs, 3rd party vendors and internal study teams.
• Develop study timelines in conjunction with the internal team and DM CRO and ensure all DM related deliverables are met.
• Oversee the development of the clinical database (DB), including user requirements, eCRF, edit rules/checks, data validation and User Acceptance Testing.
• Oversee the development of key data management documents such as case report forms (CRF), data validation specifications, manual data review guidelines, CRF Completion Guidelines, programable edit checks, Data Management Plans (DMP) and other related documents. Ensures compliance with these study documents.
• Participate in the development of other study related systems such as ePRO/eCOA and IVRS study specifications.
• Oversee all study related data cleaning activities including reconciliation with all external databases.
• Responsible for the review and accuracy of the study statement of work, RFPs, budgets, and Change Orders.
• Work with the CRO to ensure the clinical data within EDC and all external data (ex: ePRO; Labs; EKG) are in good quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock.
• Work within the Biometrics group to create and implement oversight listings, reports, programing checks and/or patient profiles.
• Responsible for the internal review of all data regularly during study conduct leading to database lock.
• Responsible for the maintenance of Oruka internal Data Review Log and working with DM vendor to get all issues resolved.
• Participate in the review of various Clinical research documents (e.g. Protocols, Safety Monitoring Plans, Communication Plans).
• Responsible for the review of all DM CRO metrics, reports and reconciliation logs to ensure quality and escalation/resolutions of issues are done in a timely matter.
• Develop, tracks, analyze and report, as applicable, on data management performance metrics from study start to database lock.
• Trouble shoots any data-related issues and finds immediate solutions.
• Create, present, and implement lessons learned related to DM activities for process improvement.
• Assist/participate in the preparation and oversight of study audits/inspections both internal and external.
• Responsible for the oversight of all DM documents in the TMF (Trial Master File) or eTMF.
• Attend and present during Study Kick Off meetings and/or Investigator Meetings
• Responsible for creating and maintaining meeting minutes for internal DM lead meetings/decision logs.
• Provide input during the development and/or review of Data Management SOPs, Work Instructions and templates/standards incorporating the industry’s best practices and any applicable Regulatory guidelines and requirements.

Clinical Data Management Manager