AVP, Clinical Data Management
Job in
Rahway, Union County, New Jersey, 07065, USA
Listed on 2026-03-02
Listing for:
MSD Malaysia
Full Time
position Listed on 2026-03-02
Job specializations:
-
IT/Tech
-
Management
Job Description & How to Apply Below
* 10+ years in progressive leadership roles managing clinical data management functions
* 10+ years of experience and demonstrated success in personnel management, including direct line management of managers in a matrixed, global organization
* 7+ years proven track record managing vendor delivery and partnerships (ex. FSPs, CROs, central labs, eCOA/ePRO, IWRS/IVRS, imaging)
* Experience leading clinical data management delivery and services across therapeutic areas and development phases, including registrational and post-marketing studies
* Experience using and/or managing data management and clinical trial technologies including EDC, encoding utilities, CTMS, eTMF, IVRS/IWRS, ePRO/eCOA, eSource, clinical data warehouses, and data reporting, visualization, and analytics platforms
* Experience using and/or managing data standards (CDISC - SDTM/ADaM, CDASH) and submissions-ready data deliverables for regulatory agencies (FDA/EMA/PMDA).
* Knowledge of full CDM lifecycle: data collection and validation design, data capture, data cleaning and reconciliation, database lock, and study close out
* Familiarity with regulatory expectations for electronic data, eSource, and data integrity (ICH E6 R3, 21 CFR Part 11)
* Working knowledge of risk-based monitoring and data cleaning strategies
* Strong analytical and problem-solving ability with a pragmatic approach to balancing timelines, quality, and cost
* High integrity and a compliance-focused mindset
* Ability to convert complex technical concepts into clear, concise, and actionable communications for non‑technical executives and cross‑functional stakeholders.
* Outstanding written and verbal communication skills that can be deployed across all levels of the organization
** Los Angeles Residents Only:
** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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