Clinical Data Manager - Contractor

TransMedics Group, Inc.•Andover, MA

32d

About The Position

The Clinical Data Manager is responsible for managing and executing data collection and management activities for the OCS Registry Studies (Lung, Heart and Liver) and provide back-up support to other studies as needed. This position is offered as a 6-month, part - time (20 hours) contract, with the potential for renewal based on performance and project needs.

Requirements

B.A./B.S. in science/health-related field and 3+ years' experience in Clinical Data Management in the Medical Device or Pharmaceutical/Biotechnology industry; or equivalent combination of education and experience
Experience with EDC system RAVE, Medrio or others a plus
Experience creating DM standards and documentation
Knowledge of industry best practices in clinical data management, and understanding of clinical trial methodology, clinical research and GCP regulations
Detail oriented with strong prioritization skills
Clear and concise in verbal and written communication, foster smooth flow of timely and relevant information
Strong initiative and positive attitude.
Proven ability to support and build collaborative relationships both internally and externally

Nice To Haves

Certified Clinical Data Manager a plus

Responsibilities

Actively participate in the entire life cycle of clinical trial data management independently.
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
Manage data management activities for assigned clinical trials such as Electronic Case Report Form (eCRF) development, database set-up activities, data validation process, SAE reconciliation), training of study site personnel in CRF completion, and data clarification processes as appropriate
Ensure the design of the eCRF is consistent with the study protocol, meets clinical requirements, and promotes accurate and efficient data collection
Collaborate with external vendors (CROs) for any outsourced activities for clinical trials
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)
Lead data management data review activities (cleaning activities including listing review, external data reconciliation and data review) and any other clinical study team data reviews required, and so ensuring completion of all activities leading to the study database lock.
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 internal SOPs
Monitor query resolutions and database locking progress and actively communicate with sites participating in clinical trials and registries to resolve data issues
Assist with the development and maintenance of data management documents, SOPs, and guidelines
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 as well as process data discrepancies
Perform other TransMedics tasks and duties as assigned