The Clinical Data Manager will provide hands-on expertise in all data management activities related to the preparation for and implementation of international clinical trials.
ESSENTIAL TASKS AND DUTIES INCLUDE:
- Actively participate in the entire life cycle of clinical trial data management. Interact and collaborate with project managers and team members to support the set-up, maintenance, and close out of the data management aspects of global clinical trials to ensure high data quality
- Participate in the design of Electronic Case Report Forms (eCRF) to ensure consistency with study protocol, clinical requirements, and accurate and efficient data collection
- Help coordinate and track progress of eCRF build to ensure projects meet deadlines and achieve high data quality standards
- Create and review data validation check specifications. Coordinate relevant parties in the development and testing of eCRF and data validation checks
- Perform thorough user acceptance testing (UAT) on eCRF and data validation checks
- Create, review and maintain project data management documents according to SOP and/or Work Instructions, including eCRF Completion Guidelines (eCCG), Data Management Plan (DMP), Data Validation Specification (DVS) etc.
- Ensure project data management documents are consistently filed within the project’s Trial Master File (TMF)
- Perform meticulous data management tasks, including proactively identifying data issues and periodically communicating with study sites, to ensure high quality of clinical data
- Monitor and create standard reports on the progress of data management tasks
- Issue and resolve queries, perform database locking according to SOP
- Monitor query resolutions and database locking progress and actively communicate with sites participating in clinical trials and registries to resolve data issues
- Help organize project team meetings and facilitate efficient project communication to ensure deadlines are met
- Provide periodic and ad hoc reports of study data and study progress
- Perform other TransMedics tasks and duties as assigned
BACKGROUND AND QUALIFICATIONS:
- B.A./B.S. in science/health-related field or equivalent plus 3+ years’ experience in Clinical Data Management in the Medical Device or Pharmaceutical/Biotechnology industry or equivalent combination of education and experience
- Advanced skills in various EDC systems, e.g. MediData Rave
- Experience in the entire life cycle of data management in clinical trials including EDC build, trial start-up, trial conduct and trial close out activities on global trials
- Experience creating DM standards and documentation
- Understanding of clinical trial methodology, clinical research and GCP regulations
- Detail oriented with strong prioritization skills
- Ability to handle multiple projects and changing priorities
- Excellent interpersonal, communication and leadership skills
- Strong knowledge of industry best practices in clinical data management
- Must be results-driven and exhibit a sense of urgency
- Certified Clinical Data Manager a plus