Associate Director, Clinical Data Management

MSD•Rahway, NJ

1d•Onsite

About The Position

The Associate Director, Data Collection Data Steward, within Global Data Management and Standards (GDMS), Global Clinical Data Standards (GCDS), provides program-level oversight of data standards. The role guides study teams in using standards libraries and first-line governance, advances new and modified standards and business processes, leads Therapeutic Area Standards Teams (TASTs), supports information governance, tracks conformance and benefits, and mentors junior staff. The position defines and maintains standard data collection definitions for electronic data capture (EDC) and non-EDC modalities, aligning them with industry standards, health authority regulations, and guidance. It supports harmonization across the clinical lifecycle, from collection through analysis, reporting, and submission. The role also provides standards expertise for study design and data transformation, supports audits and inspections, contributes to standards libraries and process improvement, and collaborates with cross-functional and global teams. The successful candidate brings deep clinical data standards and clinical development experience, including knowledge of CDISC standards, regulatory requirements, clinical data management processes, and at least one therapeutic area. The role requires strong communication, collaboration, organization, prioritization, leadership through influence, sound judgment, mentoring, and continuous improvement skills. The position is based primarily in Rahway, New Jersey, with 10% travel. Relocation is not offered, and visa sponsorship is not available.

Requirements

Associate’s degree and at least 15 years of clinical data management or standards experience (or related discipline); or a bachelor’s degree and at least 8 years; or an advanced degree (master’s or doctorate) and at least 4 years.
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 and experience with 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, ICH guidelines, 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, submission targets, and deliverables, to ensure appropriate standards application.
Ability to interpret study protocols and their requirements, facilitate cross-functional understanding of data types and sources, and translate them into high-quality, compliant data standard definitions.
Strong communication and collaboration skills across cross-functional and global teams.
Strong organization and prioritization skills, including planning across tasks, managing multiple deliverables, and providing reliable governance and status updates.
Ability to lead through influence and work effectively with geographically diverse teams and stakeholders.
Sound judgment and accountability, including effectiveness in ambiguity and managing escalations.
Leadership presence and ability to mentor, coach, and develop team members.
Continuous improvement mindset and ability to promote adoption of standardized ways of working.
Travel requirement of 10%.
No visa sponsorship is available; relocation is not offered.

Nice To Haves

Direct experience implementing industry standards such as 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 in alignment with industry standards, health authority regulations, and guidance.
Ensure data standards are harmonized across the clinical lifecycle, including collection, analysis and reporting, and submission.
Participate in and lead organizational 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.
Engage in industry forums, maintain a professional network, and influence industry strategy and clinical data standards development.
Identify trends in technology, industry standards, and regulatory requirements and assess their implications for company standards implementations.
Partner with GDMS and cross-functional teams by soliciting 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, data transformation design, and data modeling, ensuring consistency with established standards guidelines.
Serve on core study design teams and provide first-line governance support for changes to existing library forms and development of new content.
Support future standards library development, including in new therapeutic areas, and review existing SOPs, work instructions, and processes for 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 the definition and maintenance of data collection functional-area business processes and supporting technologies for defining, maintaining, applying, and sharing clinical data standards.
Prepare decision-ready leadership summaries that clearly frame risks, options, and recommendations.
Manage multiple deliverables, plan tasks, conduct risk and change control, align stakeholders and vendors, and provide status and governance updates.
Guide and review work, motivate cross-functional and geographically diverse teams, and foster an inclusive, high-trust culture.
Manage escalations and contribute to consensus on process and technology improvements, including RCA and CAPA where applicable.
Proactively identify improvements to quality, efficiency, and transparency in work practices, tools, and governance, and drive adoption of standardized ways of working.