Associate Director, Clinical Data Management

MSD•North Wales, PA

22h•$142,400 - $224,100•Onsite

About The Position

The Associate Director, Data Collection Data Steward, Global Data Management and Standards (GDMS), Global Clinical Data Standards (GCDS) provides program-level oversight of data standards, guides study teams on library use and first-line governance, and advances new or modified standards and business processes. The role leads Therapeutic Area Standards Teams (TASTs), develops and delivers training, supports information governance, tracks conformance and benefits, and mentors junior staff. The position provides expertise across one or more therapeutic areas in data collection and transformation design and data modeling. It serves as a member of assigned studies’ core design teams and provides first-line governance for changes to library forms and new content. The role supports standards libraries, process reviews, operational and study forums, and the business processes and technologies used to define, maintain, apply, and share clinical data standards. The role works with GDMS and cross-functional teams to coordinate high-quality delivery, support audits and inspections, and represent the organization in industry forums. The successful candidate will help ensure standards align with industry expectations, company processes, quality requirements, and applicable health authority regulations and guidance. The primary location is Rahway, New Jersey. Travel requirements are 10%; relocation is not offered, and visa sponsorship is not available. The position is regular, and the posting lists no shift or flexible work arrangement. The salary range for the primary location is $142,400–$224,100, with eligibility for an annual bonus and long-term incentive, if applicable.

Requirements

Associate’s degree and at least 15 years of clinical data management or standards experience, or related discipline; alternatively, a bachelor’s degree and at least 8 years of such experience; or an advanced degree (master’s or doctorate) and at least 4 years of such experience.
Expertise in clinical data standards development and implementation.
Deep knowledge of and experience applying CDISC clinical study data standards, such as CDASH, Controlled Terminology, and SDTM.
Deep understanding of clinical development trial processes, including data management and worldwide regulatory data management and reporting requirements.
Demonstrated understanding of program-level clinical and business requirements and the impact of standards.
Strong knowledge of the drug discovery process and ICH and GCP guidelines.
Demonstrated knowledge in at least one therapeutic area and ability to drive consistency across studies in a clinical development program and/or therapeutic area.
Knowledge of analysis and reporting.
Expertise in electronic data capture and external supplier data.
Ability to take an enterprise-wide view of study needs, including Controlled Terminology, SDTM, analysis and reporting, and submission targets and deliverables, to ensure appropriate standards application.
Ability to interpret study protocols and study design requirements, facilitate cross-functional understanding of data types and sources, and translate requirements into high-quality, compliant data standard definitions.
Strong communication and collaboration skills across cross-functional and global teams, including preparing concise, decision-ready leadership summaries that clearly frame risks, options, and recommendations.
Strong organization and prioritization skills, including managing multiple deliverables, planning tasks, managing risk and change control, aligning stakeholders including vendors, and providing reliable status and governance updates.
Ability to lead through influence, motivate cross-functional and geographically diverse teams, guide and review work, and foster an inclusive, high-trust culture.
Sound judgment and accountability; ability to work effectively amid ambiguity, manage escalations, and contribute to consensus on process and technology improvements, including RCA/CAPA where applicable.
Leadership presence and people-development skills, including mentoring and coaching, professional representation in internal, external, and vendor forums, and resilience under pressure.
Continuous-improvement mindset and ability to identify ways to improve quality, efficiency, and transparency in ways of working, tools, and governance.
Ability to drive adoption of standardized ways of working by engaging cross-functional partners.
Enterprise leadership skills in influence, business savviness, and networking and partnerships.

Nice To Haves

Direct experience implementing industry standards, including Controlled Terminologies, CDISC CDASH, SDTM, ADaM, and HL7, and requirements for analysis, reporting, and submission deliverables such as SDRG, ADRG, and Define.xml.
Experience managing clinical data management processes, including electronic eCRF design, clinical database development and validation, user acceptance testing, external data management, and data transformation to SDTM, analysis, and reporting.
Ability to leverage technical solutions to manage functional and/or project deliverables and associated quality.

Responsibilities

Define and maintain standard data collection definitions for EDC and non-EDC modalities, aligned with industry standards such as CDISC and with health authority regulations and guidance; ensure harmonization across collection, analysis and reporting, and submission.
Participate in and lead organization initiatives as needed.
Support audits and inspections as required.
Support assigned information governance reviews, including triage, impact assessment, curation, stakeholder feedback, and continuous improvement through TAST and SLIC governance teams.
Develop and deliver standards training and best practices to cross-functional teams.
Participate in training development and delivery, and mentor members of the Global Clinical Data Standards team.
Participate in industry forums, maintain a network of contacts, influence industry strategic direction and clinical data standards development, and identify technology, industry-standard, and regulatory trends and their implications for company standards implementations.
Partner with GDMS and cross-functional teams by seeking input, aligning priorities, and closing feedback loops to support coordinated, high-quality delivery.
Provide oversight and expertise within one or more therapeutic areas on data collection and data transformation design and data modeling, assuring consistency with established standards guidelines.
Serve as a sitting member of the core design team for assigned studies and provide first-line governance support for changes to existing library forms and new content.
Support development of future standards libraries, including in new therapeutic areas, and review existing processes in SOPs, WIs, and related materials to ensure alignment with quality requirements.
Participate in assigned operational and study team forums to ensure clinical data standards align with industry standards, company standards and processes, and information management best practices.
Support definition and maintenance of data collection functional-area business processes and supporting technologies for defining, maintaining, applying, and sharing clinical data standards.