Clinical Data Manager - Pulmonary & Critical Care Medicine

at  Washington University in St Louis

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.

EDUCATION:

Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

WORK EXPERIENCE:

Relevant Experience (5 Years)

SKILLS:

Healthcare Environments, Life Science

EDUCATION:

No additional education beyond what is stated in the Required Qualifications section.

WORK EXPERIENCE:

No additional work experience beyond what is stated in the Required Qualifications section.

SKILLS:

Clinical Research, Communication, Data Management, Drug Development, Leadership, Teamwork

• 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.
• Leads the development of clinical case report forms working in collaboration with the clinical project team, biostatistics, and other functional team leads as required.
• Coordinates the work of the assigned Clinical Data Coordinator.
• Assists the clinical project team with development of clinical case report forms.
• Assists data management vendors in database design; coordinating program development, testing, and User Acceptance Testing (UAT) of clinical databases prior to production.
• Critically reviews and maintains data management plans throughout the life-cycle of a study protocol including the development of data handling and data entry guidelines.
• Provides primary assistance in reviewing validation specifications for databases.
• Reviews electronic clinical data transfer specifications, ensures specifications, enables accurate and complete analysis in accordance with the clinical protocol.
• Tracks study progress relative to data queries, CRF pages received, data entered, etc. and issue periodic status reports to clinical project team.
• Assists with oversight of data management vendors in coding adverse events, concomitant medications, and medical history data.
• Actively participates on project team and present data management concerns; Coordinates regular Safety Review meetings, QC Review meetings, and other meetings as needed.
• Communicates project status and key project issues to project management team and all functional groups/cores as appropriate.
• Performs quality control/assurance tasks on database content/structure and data reports.
• Assists with development of procedures for ongoing/final data review and quality assurance processes.
• Leads and assists with the coordination of database locks and releases of data for analysis (through the data management vendor).
• Provides input for existing or new SOPs and other procedural documents; Development of SOPs and working practices relevant to regulatory sponsor oversight.
• Contributes to the processes for the standardization of data collection tools, formats and associated documentation (CRFs, e-CRFs, IVRS, hand-held diaries, etc.).
• Ensures the consistent implementation of procedures, data standards and data coding dictionaries across assigned studies.
• Provides input to vendor requests for information and contracts for outsourced work.
• Participates in review of invoicing for data management activities provided by the CRO vendor or other vendors as needed.
• Ensures project documentation is current on an ongoing basis and ensures that all Trial Master Filing is up to date.
• Participates in and/or assists with Investigator meetings.
• Provides input to problem-solving and implements corrective action plan when necessary.
• Maintains 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.
• Assists Administration and Clinical Operations teams in planning, developing and integrating project objectives.
• Performs other related duties as assigned to meet departmental and project objectives.