Alumis Inc. seeks a Data Management Contractor to ensure high-quality management of clinical trial data in a rapidly evolving environment, in accordance with industry standards. The contractor will support and/or lead DM activities and deliverables across one or multiple studies.
Requirements
- 10+ years of relevant experience
- BS or equivalent degree; MS or MBA a plus
- Experience running Ph I-IV clinical trials, both in-house and through CRO partners
- Strong knowledge and experience in EDC and other key technologies (e.g., IXRS, data visualization)
- Proficiency in CDISC standards (CDASH, SDTM, ADaM)
- Experience with SAS, SQL and/or other clinical programming tools
- Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP
- Depth of experience across all aspects of DM, including but not limited to: CRF and database development, data quality assurance and analytics, data transfer management, vendor management, DM study documentation and inspection readiness.
Benefits
- Onsite opportunity in South San Francisco, CA
- Open to remote applicants with requirement to be onsite 1-2x a quarter