Senior Clinical Data Manager - Katalyst Healthcares & Life Sciences
Cambridge, MA 02114
About the Job
Responsibilities
- Act as the point of contact for DM activities for multiple trials, provide oversight of data collection and management per regulatory and industry standards.
- Provide oversight of the DM CRO and ensure performance against key indicators; provide DM expertise to trial teams.
- Lead the creation of the Data Review and Cleaning Plan and development of the data cleaning strategy. Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategy.
- Review CRFs to ensure alignment with protocol; lead and perform sponsor acceptance testing of the eCRF; and ensure database structure meets expectations and provide DM insight to promote effective clinical database structure.
- Define and perform data quality checks and take action to ensure data quality.
- Drive DM oversight of data releases/DBLs and ensure timely delivery of data deliverables in accordance with Genmab SOPs and ICH/GCP; ensure data quality for analysis and reporting; prepare for regulatory filings and inspections.
- Drive and support vendor qualification for data management; define/specify scope of work for functional tasks.
- Support process improvement and knowledge management by participating in or leading task forces/projects.
- Minimum of 5 years of experience in clinical data management experience in biotech/ pharma industry with significant hands-on end-to-end experience in clinical data management practices.
- Experience with clinical trials and the drug development process.
- Significant experience leading data management activities for multiple clinical trials; proficient use of data management systems; advanced knowledge of DM processes, tools, methodologies, and documentation; strong understanding of DM strategy.
- Experience and understanding of GCPs, SOPs, regulatory requirements, and good data management practices.
- Experience with CDISC (SDTM) as well as data collection requirements in oncology trials.
- Experience with Clinical development/trial conduct, including ICH-GCP.
Source : Katalyst Healthcares & Life Sciences
