AVP, Clinical Data Management

MSD•Rahway, NJ

1d•Hybrid

About The Position

The Associate Vice President, Clinical Data Management, leads the design, execution, and continuous improvement of clinical data management processes in support of our company's global drug and vaccine development portfolio, including acquisitions and external partnerships. Reporting to the Head of Global Data Management and Standards, sets the vision for the organization and is responsible for the timely and quality execution of clinical data management services including therapeutic area, program, and study-level planning; risk and issue management; data collection and validation design; user acceptance testing; data validation and discrepancy management; change request management; database lock; and study close-out. Additional responsibilities of the Head of Clinical Data Management include: Strategic planning and alignment with broader organizational goals and priorities Development of strategies to enhance organizational value and efficiency Proactive resource forecasting and management to ensure portfolio and other organizational objectives are met Leadership of talent development and performance management activities with a focus on building a high-performing team and fostering a culture of growth and development Oversight of financial forecasting, budget, and expense management Leadership engagement with internal stakeholders and industry leaders to identify opportunities for innovation and continuous improvement Ensuring process alignment with regulatory expectations and industry best practice Sponsorship and/or leadership of organizational initiatives Enterprise Leadership Skills – behaviors and impact expected in this role include: Strategic Planning: Thinks strategically and gains alignment through collaborative stakeholder engagement and influence across development, clinical operations, regulatory, safety, and IT. Execution Excellence: Drives reliable, high‑quality delivery by establishing end‑to‑end processes and KPI‑driven measurement approaches (e.g., time‑to‑lock, query rates, error reduction) to track progress, improve outcomes, and ensure consistent, submission‑ready outputs across global and vendor‑delivered studies. Change Catalyst: Adapts to change and energizes teams through clear, compelling communication at all levels. Networking & Partnerships: Proactively builds and sustains strategic internal and external relationships (cross‑functional leaders, vendors, alliance partners, customers) to accelerate CDM objectives.

Requirements

15+ years in clinical data management within the pharmaceutical or biotech industry
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
Required: Bachelor’s degree in life sciences, biostatistics, health informatics, or related field

Nice To Haves

Advanced training or certification in clinical research and/or data management relevant disciplines including, but not limited to: Association of Clinical Research Professional (ACRP) certification; SCDM Clinical Data Manager (CCDM) certification, Project Management Professional (PMP) certification

Responsibilities

Strategic planning and alignment with broader organizational goals and priorities
Development of strategies to enhance organizational value and efficiency
Proactive resource forecasting and management to ensure portfolio and other organizational objectives are met
Leadership of talent development and performance management activities with a focus on building a high-performing team and fostering a culture of growth and development
Oversight of financial forecasting, budget, and expense management
Leadership engagement with internal stakeholders and industry leaders to identify opportunities for innovation and continuous improvement
Ensuring process alignment with regulatory expectations and industry best practice
Sponsorship and/or leadership of organizational initiatives