Senior Clinical Data Manager (RAVE)

Description

• Provide leadership and guidance to the data management team
• Create, track, and manage data management timelines, proposals, and budgets.
• Provide support and act as the data management point person to the Sponsor, CROs, vendors, clinical sites, and scorers
• Develop and maintain good communications and working relationships with Clinilabs project team members as well as Sponsor, CRO, vendor, and clinical site project team members
• Develop presentations and present at Investigator meetings
• Train, track, and manage users (Sponsors, Sites, Investigators and other study personnel) on the CDMS
• Manage delivery of projects through full data management process life-cycle, including but not limited to:
  • CRF/eCRF design from protocol
  • Creation of CRF/eCRF Completion Guidelines
  • Database design, set-up, acceptance testing in the CDMS
  • Creation of the study Data Management Plan and Edit Check Specifications
  • Edit check programming and validation in the CDMS
  • Perform study change control as needed
  • Manage and oversee both site and internal data entry and query resolution
  • Perform data reviews
  • Generate requested data management reports
  • Perform query generation/tracking and oversee query resolution
  • Perform and oversee vendor data imports and transfers
  • Perform and oversee MedDRA and WHODrug coding
  • Perform database lock activities
• Creation, completion, organization, and tracking of all data management documentation
• Determine project and department resource needs and data management responsibilities
• Consult with supervisors for process issues and communicate ideas for process improvement
• Assist in developing and implementing new technology
• Develop, edit, and review Standard Operating Procedures and Work Instructions as needed
• Oversee, track, and document both internal training (e.g. Standard Operating Procedures/Work Instructions, study-specific training) and external training (e.g. site CRF and EDC training)
• Follow and ensure compliance with current Good Clinical Practices (cGCPs)
• Adhere to corporate policies and procedures
• Perform other duties as required or assigned