Specialist Clinical Development

South San Francisco, CA Contract Duration: 12-36 months Rate: Negotiable Salary: NA, $1.00Responsibilities: Excellent employment opportunity for a Specialist Clinical Development in the South San Francisco, CA area. Participates 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 Represents data management in study team meetings Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols) Executes and/or distributes data management metrics, listings, and reports, as required Oversight of data management CRO/service providers on assigned studies Monitors the progress of all data management activities on assigned studies to ensure project timelines are met Provides 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 Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email

Created: 2026-04-15