Senior Clinical Data Manager - Katalyst Healthcares & Life Sciences
South San Francisco, CA 94015
About the Job
Responsibilities:
- Serve as a data management expert and be the CDM lead for assigned clinical studies on multidisciplinary project teams.
- Deliver high quality data for analysis and study milestones.
- Review protocols from a CDM perspective and provide functional-expert feedback.
- Review and approve key clinical data management deliverables generated by the CDM vendor including Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding, data listing specifications, and electronic data transfer agreements.
- Manage/oversee study setup, testing and system validation for new studies in partnership with the DM vendor
- Oversee data cleaning activities executed by the CDM vendor and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data.
- Collaborate with internal Data Science (statistical programming), internal Biostatistics, and internal Medical Monitor on identifying critical variables in the clinical dataset, for protocol-specified endpoints. Coordinate implementing these variables into DM vendor activities.
- Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management vendor and Denali project team.
- Monitor vendor performance to ensure timelines and data quality standards are met.
- Ensure compliance of clinical data management processes with applicable regulations and guidelines.
- BA/BS or higher preferably in math, science, or health-related field.
- Minimum of 4+ years of experience in relevant field with at least 2+ years acting as the lead clinical data manager. Experience on all study phases including early phase, dose escalation is greatly preferred.
- CNS/Neurodegenerative trial experience is greatly preferred.
- Comprehensive experience working with clinical database systems.
- Working knowledge of CDISC including CDASH, TAUG and SDTM as well as data privacy regulations e.g. GDPR.
- Able to work in a fast paced and dynamic environment while effectively managing multiple projects which may have changing priorities.
- Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors.
- Clear verbal and written communication skills.
- Strong analytical and problem-solving skills.
Source : Katalyst Healthcares & Life Sciences