Clinical Data Manager III

Job Duties And Responsibilities

• For specified projects performs start-up activities including:
  • Developing data management guidelines and study documentation
  • Review of CRF design against protocol
  • Lead study developing core study documents for data management including DMP, DVP, CRF completion guidelines, and other study documentation.
  • Activities include design, database structure, document creation; including approval
• For specified projects performs data management activities as detailed below and performs activities in accordance with our SOPs, Good Clinical Practice, ICH Guidelines and study documentation.
  • Study status tracking
  • Review of data listings
  • Identification of data issues and query generation
  • Updating of database with query resolutions (paper studies only)
  • Processing and reconciliation of external data including SAE reconciliation
  • Ownership and proactive management of the data reconciliation activities documented in the DVP, DMP, etc.
  • Provide input for Database closeout and lock activities and timelines
  • Archiving of critical documents on an ongoing basis
• If assigned the Lead Data Manager role, act as key data management contact for the project.
  • Awareness of the CAPA process and provide input for audit responses regarding assigned tasks
  • Proactive management of project quality through supervision and quality control of team members’ work
  • Proactive participation in appropriate sponsor/project team meetings
  • Active involvement in departmental and organizational meetings and initiatives
  • Develops and documents departmental procedures
  • Training and Mentoring of team members in accordance with established departmental procedures
  • Supports and tracks budget adherence in cooperation with Finance to ensure the assigned studies are meeting targeted margins and utilization
  • Continuous improvement of departmental processes and procedures to ensure DM is consistently maximizing efficiencies, leveraging technology and incorporating innovation to optimize delivery
  • Maintains working knowledge of regulatory requirements/guidance as well as industry leading best practices to ensure Caidya DM procedures are in line with industry expectations
  • Indirect supervision of the work of junior members of the project team
• Other duties as assigned.

Supervisory Responsibilities

No supervisory responsibilities.