Sr. Clinical Data Manager -8979

Responsibilities: Excellent employment opportunity for a Sr. Clinical Data Manager in the San Francisco, CA area. Participate in the development, review and implementation of departmental SOPs, templates and processes Support budget and resource planning across assigned projects Contribute to technical infrastructure of data management Participate in CRO/vendor selection process for outsourced activities Represent data management in study team meetings Manage data management timelines to coordinate and synchronize deliverables with the overall study timelines Generate and/or review/approve study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols) Execute and/or distribute data management metrics, listings, and reports, as required Oversight of data management CRO/service providers on assigned studies Monitor the progress of all data management activities on assigned studies to ensure project timelines are met Provide training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed Proactively identifies potential study issues/risks and recommends/implements solutions Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables Experience: Bachelor degree in Life Sciences, Computer Sciences, Mathematics, or health-related field Minimum of 5 years of SENIOR-LEVEL DM (i.e., Sr. CDA) experience in the pharmaceutical or biotechnology industry or equivalent; depth and exposure to DM related tasks considered in lieu of minimum requirement CRO management experience desired Competence in SAS programming a plus Prior oncology/hematology experience highly desirable Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements Excellent verbal/written and interpersonal skills required for working successfully in a cross- functional team environment Good working knowledge of ICH, FDA, and GCP regulations and guidelines Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint) Knowledge of industry standards (CDISC, SDTM, CDASH) Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug. Proven ability to work both independently or in a team setting

Created: 2026-04-19