Clinical Data Manager
Lawrence , MA 01810 US
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Title: Clinical Data Manager
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: Perm
- Pay rate: $70-75k
- Job Location: Lawrence, MA
- Job# 14452
Clinical Data Manager
The Clinical Data Manager I is responsible for executing the design, documentation, testing, and implementation of data collection systems and processes through the life cycle of 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
- With support, 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
- 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)
- 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
BACKGROUND AND QUALIFICATIONS:
- B.A./B.S. in science/health-related field and 2+ 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
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