Clinical Data Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee comprehensive clinical data management processes for companion diagnostic studies, encompassing data acquisition, database design, data review, external data integration, reconciliation, quality control, database locking, and the creation of submission-ready datasets that facilitate global regulatory submissions.

• Direct the design, validation, user acceptance testing (UAT), maintenance, and database locking activities of EDC/CRF systems to meet regulatory reporting requirements for CDx studies in compliance with relevant regulations and company policies.

• Collaborate with Biostatistics and Programming teams to ensure the development of submission-ready SDTM and ADaM datasets that support PMA, 510(k), De Novo, NDA, and BLA submissions.

• Assist in the preparation of submission-ready clinical data packages for FDA PMA, PMA supplements, 510(k), NDA/BLA companion diagnostic submissions, and international regulatory filings, including EU IVDR.

• Implement risk-based data management principles to identify critical data and proactively address data quality risks throughout the study lifecycle.

• Maintain inspection readiness by ensuring the availability of complete, traceable, and auditable records, while serving as a clinical data management subject matter expert during audits and regulatory inspections.

• Create Data Transfer Specifications that outline deliverables, formats, and timelines; serve as the primary point of contact for internal teams and pharmaceutical partners.

• Write and maintain data management documentation throughout the study lifecycle, which includes SOPs, process flows, data management plans, CRFs, and database specifications.

• Act as a subject matter expert (SME) representing Agilent externally and OCMO internally, working with cross-functional teams (Clinical Development, Clinical Operations, CROs, Pharmaceutical Partners, Biostatistics, Quality Affairs/Design Assurance, and Regulatory Affairs) to coordinate data-related activities and ensure accurate, compliant, and timely data transfers.

• Exhibit proficiency in data format standards (e.g., CDISC SDTM ADaM and LAB) and their integration with various EDC platforms.

• Conduct quality control checks to guarantee accurate, complete, and compliant data for Agilent's internal projects and external data submissions to pharmaceutical partners.

• Identify and escalate data integrity issues; propose process enhancements as necessary.

• Plan, coordinate, and oversee data management activities across programs to ensure consistency in clinical data standards.

• Serve as the Data Management Subject Matter Expert for Agilent’s BioPharma CDx Services Lab (BCSL).

⛳️ Requirements

• Bachelor's degree in Data Science, Computer Science, Information Technology, or a related field OR a Master's degree or advanced degree (e.g., Ph.D., Pharm. D., M.D.) in pharmaceutical, medical, or relevant biomedical sciences with experience in data management.

• An advanced degree is preferred.

• A minimum of 5-8 years of clinical data management experience in biotechnology, pharmaceuticals, medical devices, diagnostics, or companion diagnostic development.

• Practical experience with CDISC standards, including SDTM, ADaM, CDASH, and Define.xml.

• Proven experience in designing and managing studies utilizing EDC platforms such as Medidata Rave, Veeva CDMS/EDC, Oracle InForm, REDCap, or equivalent systems.

• Direct experience in supporting oncology clinical trials, biomarker-driven studies, companion diagnostics, precision medicine programs, or regulated IVD development is strongly preferred.

• Ability to interpret regulatory standards, guidelines, and laws.

• Exceptional capability to manage multiple projects in a dynamic environment with shifting priorities.

• Must possess the ability to work independently, interpret complex scientific and clinical data, and take the initiative to lead projects and assignments.

• Experience working with external partners and/or regulatory agencies.

• Knowledge of cancer diagnostics, Oncology, and/or Pathology is preferred.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development

• Bonuses

• Stock options