Senior Clinical Data Manager - Katalyst Healthcares & Life Sciences
Hayward, CA 94540
About the Job
Responsibilities:
- As a Senior Clinical Data Manager, you will develop strategies, lead data management activities, and interface with the project team to ensure that data management services are delivered consistently and in a high-quality manner.
- You will also independently perform and oversee tasks related to database and report setup and processing and cleaning clinical trial data, following all applicable standard and study-specific procedures.
- Serve as a data management expert and, if assigned, 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 a DM 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 and oversee study setup, testing, and system validation for new studies in partnership with the DM vendor.
- Perform and oversee data cleaning activities executed by the DM vendor and ensure protocol-specified guidelines are applied to the review and cleaning of clinical data.
- Collaborate with internal Data Science (statistical programming), Biostatistics, and Medical Monitor teams to identify critical variables in the clinical dataset for protocol-specified endpoints.
- Coordinate the implementation of 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 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 in math, science, or health-related field.
- 5+ years of experience in clinical data management acting as a study lead data manager across phase 1-3 clinical trials.
- Comprehensive experience working with clinical database systems.
- Working knowledge of CDISC, including CDASH, TAUG, and SDTM, as well as data privacy regulations (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 multidisciplinary project teams and develop productive relationships with external vendors.
- Clear verbal and written communication skills.
- Strong analytical and problem-solving skills.
- Clinical data management, clinical trial, clinical database, CDISC, CDASH, TAUG, SDTM, GDPR.
Source : Katalyst Healthcares & Life Sciences