Senior Director, Clinical Data Management. - Hybrid

MSD; North Wales (Montgomery County); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation days

Sick days

Job summary

MSD is seeking a Senior Director of Data Collection Data Steward to set strategy, govern data standards, and lead the Standards team. You will drive enterprise metrics, manage budgets, and communicate outcomes to executives while representing the company externally.

You will oversee standards creation, training, and collaboration with GDMS, GCTO, GCDS, and external partners, ensuring compliance with CDISC, ICH, and regulatory requirements.

Qualifications

• Bachelor’s degree required; 13+ years in Clinical Data Management or related field.
• 3+ years in clinical data standards development or metadata management.
• Minimum 5 years of people management experience.

Responsibilities

• Provide governance oversight for data collection standards (EDC and non-EDC) aligned with CDISC and regulatory guidance.
• Lead cross-functional initiatives; forecast resources and optimize processes across GDMS/GCTO and GCDS.
• Develop and deliver standards training; mentor the Global Clinical Data Standards team.

Skills

Strategic thinking

Leadership

People management

CDISC standards

Regulatory knowledge

Data governance

Education

Bachelor’s Degree in a relevant field

Job description

Job Description The Senior Director, Data Collection Data Steward serves on the GCDS Leadership Team to set strategy and oversee the standards delivery framework, governance, and operations (planning, resourcing, process excellence, and innovation). Drive enterprise metrics and outcomes, act as an escalation point for governance, represent the company externally, and lead people management (objectives, talent, budgets, and communications).

Responsibilities

Provide oversight and guidance to teams as they define and maintain standard data collection (EDC [Electronic Data Capture] and non-EDC modalities) definitions aligned with industry standards (e.g., CDISC [Clinical Data Interchange Standards Consortium]) and Health Authority regulations and guidance. Identify opportunities, lead, or participate in organizational initiatives as needed. Support audits and inspections as required. Accountable for the management and timely delivery of standards and governance deliverables, coordinating efforts across GCDS sub-units including resource forecasting, process optimization, operations reviews, and strategic innovation initiatives. Provide oversight and strategic direction to the design and delivery of Standards training and best practices to cross functional teams. Provide oversight and strategic direction to teams in the development of training materials, training delivery, and mentoring of the Global Clinical Data Standards team. Act as a leader in industry forums, maintaining network of contacts, and influence industry strategic direction and clinical data standards development. Build and sustain senior stakeholder networks across GDMS/ Global Clinical Trial Operations (GCTO)/ GCD [Global Clinical Development]) and strategic partners; broker decisions and remove systemic blockers. Provide oversight and expertise within one or multiple TAs on data collection/data transformation design and data modeling to all staff, assuring consistency with established standards guidelines. Ability to provide strategic direction and participate in multiple Standards governance initiatives, forums, and reviews (e.g., TAST [Therapeutic Area Standards Team], SLIC [Shared Clinical Data Standards Council]). Lead and/or actively participate in cross-functional (e.g., GDMS/GCTO/GCD [Global Clinical Development]) strategic projects. Serve as an escalation point for study-level design, as needed. Provide oversight and strategic direction to teams in development of future standards libraries and/or new/modified processes. Develop the strategic direction for new processes and tools supporting clinical data standards and information management capabilities. Provide oversight and communication of the implementation plans to cross-functional stakeholders and executive management, as appropriate. Provide prioritization and oversight of standards metrics. Communicate metrics cross-functionally to Executive Leadership. Work with fellow GCDS leadership on prioritization and delivery of the Book of Business, new functional programs/projects, and governance demands. Act as an escalation point on governance decisions, including changes to existing library forms and new content. Working in collaboration with GCDS ELT to define the strategic direction and prioritization for the data collection libraries and associated components. Serve as a core member of the GCDS (Global Clinical Data Standards) Leadership Team and proactively engage with stakeholders inside and outside of GCDS and across global sites to drive efforts critical to the success of GCDS and GDMS (Global Data Management and Standards) more broadly.

People Management Responsibilities

Set clear objectives aligned to organizational goals; assign work and set priorities. Conduct regular check‑ins and annual reviews; coach for performance; provide recognition. Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring. Lead recruiting and hiring; manage sensitive employee‑relations matters in partnership with HR. Balance workloads to support value‑added work and work‑life sustainability; anticipate obstacles and adjust plans. Coordinate on‑shore/off‑shore and contingent resources; ensure role clarity and effective handoffs. Manage an operating budget and optimize spend against priorities. Align teams around a clear direction; facilitate team/functional meetings. Provide concise, decision‑ready updates and status reporting to leadership and partners.

Technical skills

Extensive experience managing and governing clinical information standards and related activities, including the development and implementation of clinical data standards. Deep knowledge of and experience with applying industry standards (e.g., Controlled Terminologies, CDISC [Clinical Data Interchange Standards Consortium], CDASH [Clinical Data Acquisition Standards Harmonization], SDTM [Study Data Tabulation Model], ADaM [Analysis Data Model], & HL7 [Health Level Seven International]) and requirements for analysis & reporting and submission deliverables (e.g., SDRG [Study Data Reviewer’s Guide], ADRG [Analysis Data Reviewer’s Guide], Define.xml) Deep understanding of and experience with clinical development trial processes, including data management and worldwide regulatory DM (Data Management) & reporting requirements. Demonstrate understanding of program‑level clinical and business requirements and impact of standards. Strong knowledge of the Drug Discovery Process, ICH (International Council for Harmonization) and GCP (Good Clinical Practice) guidelines. Demonstrate advanced knowledge across multiple (>2) therapeutic areas with ability to drive consistency across all studies in clinical development programs and / or therapeutic areas. Knowledge of Analysis & Reporting. Electronic Data Capture and external supplier data expertise. Ability to take an enterprise‑wide view of study needs that is inclusive of Controlled Terminology, SDTM, analysis and reporting, and submission targets and deliverables to ensure appropriate application of standards. Ability to interpret the study protocol as it relates to study design. Ability to interpret protocol requirements to facilitate cross‑functional understanding of data types and sources which are then translated into high quality, compliant data standard definitions.

Preferred Skills

US and Puerto Rico Residents Only:

Qualifications & Experience

Bachelor’s Degree and minimum of 13 years' experience in Clinical Data Management (or related discipline), including; 3 years needs to be in clinical data standards development or metadata management Minimum of 5 years people management experience (direct or matrix) Demonstrated deep subject matter expertise OR Advanced Degree (Masters or Doctorate) and minimum of 10 years experience in Clinical Data Management (or related discipline), including: 3 years needs to be in clinical data standards development or metadata management Minimum of 5 years people management experience Demonstrated deep subject matter expertise #eligibleforERP

Required Skills

Clinical Development, Clinical Study Protocols, Data Governance, Data Management, Data Standards, Enterprise Leadership, Information Management, People Management, Strategic Thinking, Study Design

• Available benefits include medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location. Additional location(s) Compensation Information: San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance 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

Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 11/16/2026 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.