Clinical Data Manager

We are searching for an experienced Clinical Data Manager to work within the in-vitro diagnostic field as a key member of the Organization of Chief Medical Officer (OCMO) Global Clinical Affairs team. 

The Clinical Data Manager will plan and oversee all data management activities across assigned studies related companion diagnostics (CDx) development to ensure timely, accurate, and compliant data delivery. They will develop data transfer specifications, support the development of data transfer agreements, manage CRF/EDC systems, perform instream data monitoring, and maintain data in reporting platforms. The role will collaborate with cross-functional teams and external partners to resolve queries and uphold relevant quality standards and regulatory requirements. Additionally, they will author data management documentation, monitor data integrity, implement process improvements, and work on multiple complex projects to support successful CDx activities. 
 
Responsibilities include but are not limited to: 

• Lead end-to-end clinical data management activities for companion diagnostic studies, including data acquisition, database design, data review, external data integration, reconciliation, quality control, database lock, and preparation of submission-ready datasets supporting global regulatory submissions. 

• Lead EDC/CRF system design, validation, user acceptance testing (UAT), maintenance, and database lock activities to support CDx study regulatory reporting requirements in accordance with applicable regulatory requirements and company procedures. 

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

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

• Apply risk-based data management principles to identify critical data and proactively mitigate data quality risks throughout study execution. 

• Ensure inspection readiness through maintenance of complete, traceable, and auditable records, and serve as a clinical data management SME during audits and regulatory inspections. 

• Develop Data Transfer Specifications detailing deliverables, formats, and timelines; act as the primary liaison for internal teams and pharmaceutical partners. 

• Author and maintain data management documentation throughout the study lifecycle, including SOPs, process flows, data management plans, CRFs, and database specifications. 

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

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

• Perform quality control checks to ensure accurate, complete, and compliant data for Agilent internal projects and external data deliverables to pharmaceutical partners. 

• Identify and escalate data integrity issues; recommend process improvements as needed. 

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

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

• Apply strong knowledge of GCP, ICH, and regulatory requirements to support CDx submissions and communicate effectively to build internal programs. 

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

• Minimum 5-8 years of clinical data management experience in biotechnology, pharmaceutical, medical device, diagnostics, or companion diagnostic development. 

• Hands-on experience with CDISC standards including SDTM, ADaM, CDASH and Define.xml. 

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

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

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

• Exceptional ability to manage multiple projects in a fast-paced environment with changing priorities. 

• Must be able to work and make independent decisions, understand complex scientific and clinical data information, and be able to take the initiative to lead projects and assignments. 

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

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