Scheduled Hours

40

Position Summary

Acts as DIAN-TU Clinical Data Management functional lead and assists Clinical Operations team with the data management process life cycle (e.g., CRF Design through Database Lock) in coordination with Contract Research Organizations (CROs), data management vendors, service providers, DIAN-TU cores and statistical teams to ensure the accurate, efficient and complete data collection for DIAN-TU clinical trials.

Job Description

Primary Duties & Responsibilities:

• Responsible for project oversight of all data management activities for assigned studies.
• Primary contact for Contract Research Organizations (CROs) performing data management activities for assigned studies.
• Lead the development of clinical case report forms working in collaboration with the clinical project team, biostatistics, and other functional team leads as required.
• Coordinate the work of the assigned Clinical Data Coordinator.
• Assist data management vendors in database design; coordinating program development, testing, and User Acceptance Testing (UAT) of clinical databases prior to production. 
• Critically review and maintain data management plans throughout the life-cycle of a study protocol including the development of data handling and data entry guidelines.
• Provide primary assistance in reviewing validation specifications for databases.
• Review electronic clinical data transfer specifications and ensure specifications enable accurate and complete analysis in accordance with the clinical protocol.
• Track study progress relative to data queries, CRF pages received, data entered, etc. and issue periodic status reports to clinical project team.
• Assist with oversight of data management vendors in coding adverse events, concomitant medications, and medical history data.
• Actively participate on project team and present data management concerns; coordinate regular Safety Review meetings, QC Review meetings, and other meetings as needed.
• Communicate project status and key project issues to project management team and all functional groups/cores as appropriate.
• Perform quality control/assurance tasks on database content/structure and data reports.
• Assist with development of procedures for ongoing/final data review and quality assurance processes.
• Lead and assist with the coordination of database locks and releases of data for analysis (through the data management vendor).
• Provide input for existing or new SOPs and other procedural documents; development of SOPs and working practices relevant to regulatory sponsor oversight.
• Contribute to the processes for the standardization of data collection tools, formats and associated documentation (CRFs, e-CRFs, IVRS, hand-held diaries, etc.).
• Ensure the consistent implementation of procedures, data standards and data coding dictionaries across assigned studies. 
• Provide input to vendor requests for information and contracts for outsourced work.
• Participate in review of invoicing for data management activities provided by the CRO vendor or other vendors as needed.
• Ensure project documentation is current on an ongoing basis and ensures that all Trial Master Filing is up to date.
• Participate in and/or assists with Investigator meetings.
• Provide input to problem-solving and implements corrective action plan when necessary.
• Maintain a good working knowledge of regulatory guidelines relevant to clinical data management (i.e., ICH/GCP and 21 CFR Part 11 Electronic Records and CDISC) and related SOPs.
• Assist Administration and Clinical Operations teams in planning, developing and integrating project objectives.
• Other related duties as assigned to meet departmental and project objectives.

Working Conditions:
Job Location/Working Conditions

• Very busy office environment with frequent moderate/high pressure caused by deadlines

• After hours or weekend responsibility due to urgent situations and international duties

• Able to fly to various meetings (domestic and international) at investigator, pharma partner, trial, vendor or regulatory agency sites

Physical Effort

• Typically sitting at desk or table

• Repetitive wrist, hand, or finger movement

Equipment

• Office equipment

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties