Clinical Data Manager

About this role

Job Description

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.  

Qualifications

• 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.  

Additional Details

This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least August 5, 2026 or until the job is no longer posted.

The full-time equivalent pay range for this position is $105,280.00 - $197,400.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a p

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