What are the responsibilities and job description for the Clinical Data Manager - Contractor position at TransMedics, Inc.?
Job Description
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.
Essential Tasks And Duties Include
Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
Dental
Vision
Healthcare Flexible Spending Account
Dependent Care Flexible Spending Account
Short Term Disability
Long Term Disability
401K Plan
Pet insurance
Employee Stock Purchase Plan
TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
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.
Essential Tasks And Duties Include
- 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
- 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
- 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
- Certified Clinical Data Manager a plus
- BS/BA in science/health-related field or equivalent combination of education and experience
Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
Dental
Vision
Healthcare Flexible Spending Account
Dependent Care Flexible Spending Account
Short Term Disability
Long Term Disability
401K Plan
Pet insurance
Employee Stock Purchase Plan
TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.