Associate Director, Clinical Data Management

Merck•North Wales, PA

1d•$142,400 - $224,100

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 in using standards libraries and first-line governance, and advances new or modified standards and business processes. The role leads Therapeutic Area Standards Teams (TASTs), training, and information-governance support; tracks conformance and benefits; and mentors junior staff. The position defines and maintains standardized data-collection definitions for electronic data capture (EDC) and non-EDC modalities, aligned with industry standards such as CDISC and with health-authority regulations and guidance. It ensures standards are harmonized across collection, analysis and reporting, and submission. The role provides expertise in data-collection and data-transformation design and data modeling, participates in study design teams and governance forums, and supports the development and maintenance of standards libraries, processes, and related technologies. The Associate Director also supports audits and inspections, leads or participates in organizational initiatives, delivers standards training, engages with industry forums, and partners with GDMS and cross-functional teams to coordinate priorities and high-quality delivery. The role identifies developments in technology, industry standards, and regulatory requirements and assesses their implications for standards implementation. The position is based primarily in Rahway, New Jersey. The posting lists 10% travel, no relocation, and no visa sponsorship. Flexible work arrangements are listed as not applicable, and the shift is not indicated.

Requirements

Associate’s degree and at least 15 years of clinical data management or standards experience, or a related discipline; or 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 translate protocol requirements into a cross-functional understanding of data types and sources and into high-quality, compliant data-standard definitions.
Strong communication and collaboration skills across cross-functional and global teams, including the ability to prepare concise, decision-ready leadership summaries that frame risks, options, and recommendations.
Strong organization and prioritization skills, including managing multiple deliverables, planning tasks, risk and change control, stakeholder and vendor alignment, and governance updates.
Ability to lead through influence, motivate geographically diverse teams, guide and review work, and foster an inclusive, high-trust culture.
Sound judgment and accountability; ability to work in ambiguity, manage escalations, and contribute to process and technology improvements, including RCA and 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 improvements to quality, efficiency, transparency, tools, governance, and ways of working.
Ability to drive adoption of standardized ways of working with cross-functional partners.
Enterprise leadership skills in influence, business analysis, networking, and partnership-building.

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 use 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 and health-authority regulations and guidance.
Ensure standards are harmonized across the clinical lifecycle, including collection, analysis and reporting, and regulatory 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.
Participate in industry forums, maintain professional contacts, influence industry direction and standards development, and assess implications of technology, standards, and regulatory developments.
Partner with GDMS and cross-functional teams, seek input, align priorities, and close feedback loops to support coordinated, high-quality delivery.
Provide oversight and expertise across one or more therapeutic areas for data-collection and data-transformation design and data modeling, ensuring consistency with established standards guidance.
Serve on core design teams for assigned studies and provide first-line governance for changes to existing library forms and new content.
Support development of future standards libraries, including for new therapeutic areas, and review existing processes such as SOPs and work instructions for alignment with quality requirements.
Participate in assigned operational and study-team forums to ensure clinical data standards align with industry and company standards, 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.