Clinical Data Manager - Katalyst Healthcares & Life Sciences
Bedford, MA
About the Job
Responsibilities:
- Lead and/or support Data Management start-up activities, such as development and review of protocols, EDC database development documentation and activities, eCRF Completion Guidelines, Data Management Plans, and cross functional collaboration.
- Ensure data collected in the clinical and vendor databases meets the requirements for analysis, including development and maintenance of Data Transfer Agreements and vendor data transfer workflow.
- Participate in all aspects of data cleaning and review, including routine data cleaning, third party data reconciliation, query management, metrics reporting, and cross functional data health communication and documentation.
- Review and contribute to cross functional study documents, such as Protocols, Clinical Monitoring Plans, Statistical Analysis Plans, Safety Monitoring Plans, and presentation slide decks.
- Maintain all Data Management documentation, ensuring preparedness for regulatory inspections.
- Collaborate with internal and external stake holders for data transfers and data analytics activities.
- May develop, review, and revise SOPs, Work Instructions, and Templates.
- Bachelor's Degree, or commensurate experience, with at least 5 years' experience in Clinical Data Management with a Pharmaceutical, Biotech, CRO, or Academic Centre. Oncology preferred.
- Excellent verbal and written communication skills. Ability to communicate Data Management and EDC technical concepts to cross functional groups for awareness and understanding.
- Robust experience with EDC systems. Medidata skills strongly preferred. This includes, but is not limited to, awareness of iMedidata Cloud User and Site Administration, experience with Rave Local Lab Administration, Rave Coder, RTSM or other IRT system integrations, Rave Safety Gateway, and Rave Imaging.
- Advanced awareness of data collection and data cleaning best practices.
- Firm understanding and proven success managing vendors and data transfer workflows.
- Practical knowledge of ICH, FDA, and GCP regulations and guidelines, and general knowledge of industry data collection and reporting standards and best practices, such as SDTM and CDISC/CDASH.
Source : Katalyst Healthcares & Life Sciences