Clinical Data Manager

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 supportCDxstudy regulatory reporting requirementsin accordance withapplicable 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,NDAand 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 andmaintaindata 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.

Demonstrateexpertisein data format standards (e.g., CDISC SDTMADaMand LAB) and integration with various EDC platforms.

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

Identifyand escalate data integrity issues; recommendprocessimprovements as needed.

Plan, coordinate, and manage data management activities across programs tomaintainconsistency in clinical data standards.

Act as Data Management Subject Matter Expert for Agilent’s BioPharmaCDxServices Lab (BCSL)

Apply strong knowledge of GCP, ICH, and regulatory requirements to supportCDxsubmissions 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,medicalor 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, OracleInForm,REDCapor equivalent systems.

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

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 preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required:

No

Shift:

Day

Duration:

No End Date

Job Function:

Medical/Clinical