Job Description

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, guiding study teams on library use and first-line governance while advancing new/modified standards and business processes. Lead Therapeutic Area Standards Teams (TASTs), training, support information governance, track conformance/benefits, and mentor junior staff.

Responsibilities

• 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; ensure harmonization across the clinical lifecycle (collection, analysis and reporting, and submission).
• Participate and lead organization initiatives as needed.
• Support audits and inspections as required.
• Support assigned information governance reviews (e.g., triage, impact assessment, curation, and stakeholder feedback/continuous improvement) via TAST (Therapeutic Area Standards Teams) and the SLIC (Shared Clinical Data Standards Council) governance teams.
• Develop and deliver Standards training and best-practices to cross-functional teams.
• Participate in training development, training delivery, and mentoring to members of the Global Clinical Data Standards team.
• Engage in industry forums, maintaining network of contacts, and influence industry strategic direction and clinical data standards development. Identify trends in developments of technologies, evolution in industry standards and regulatory requirements, and identify implications on our company's standards implementations.
• Act as a reliable partner to GDMS and other cross-functional teams, actively seeking input, aligning on priorities, and closing feedback loops to drive high-quality, coordinated delivery.
• Provide oversight and expertise within one or multiple TAs (Therapeutic Areas) on data collection/data transformation design and data modeling to all staff, assuring consistency with established standards guidelines.
• Work 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 the development of future standards libraries (including in new therapeutic areas) and reviews of existing processes within SOPs (Standard Operating Procedures), WIs (Work Instructions), etc., ensuring they are in-line with quality requirements.
• Participate in assigned operational and study team forums ensuring clinical data standards align with industry standards, our company's standards and processes, and information management best practices.
• Support the definition and maintenance of the data collection Functional Area business processes and supporting technologies related to the definition, maintenance, application, and sharing of clinical data standards.

Technical skills

• Expertise in clinical data standards development and implementation.
• Deep knowledge of and experience with applying CDISC Clinical Study Data standards (e.g., CDASH [Clinical Data Acquisition Standards Harmonization], Controlled Terminology, SDTM [Study Data Tabulation Model]).
• Deep understanding of and experience with clinical development trial processes, including data management and worldwide regulatory DM (Data Management) & reporting requirements.
• Demonstrated 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.
• Demonstrated knowledge in at least 1 TA with ability to drive consistency across all studies in a clinical development program and/or therapeutic area.
• Knowledge of Analysis & Reporting.
• Expertise in electronic Data Capture and external supplier data.
• 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:

• Direct experience implementing industry standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, 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).
• Experience managing clinical data management processes including electronic eCRF (electronic Case Report Form) design, clinical database development and validation, user acceptance testing, external data management and knowledge of data transformation to SDTM, and analysis & reporting.
• Ability to leverage technical solutions to manage functional and/or project deliverables and associated quality with assigned projects.

Non-technical knowledge, skills, and abilities

• Strong communication and collaboration across cross-functional and global teams; crafts concise, decision-ready summaries for leadership, clearly framing risks, options, and recommendations.
• Strong organization and prioritization, managing multiple deliverables, planning across tasks, running risk/change control, aligning stakeholders (including vendors), and providing reliable status and governance updates.
• Ability to lead through influence, motivating cross-functional and geographically diverse teams, guiding and reviewing work, and fostering an inclusive, high-trust culture.
• Sound judgment and accountability, operating effectively in ambiguity, managing escalations, and contributing to consensus on process and technology improvements (including RCA [Root Cause Analysis]/ CAPA [Corrective and Preventive Action] where applicable).
• Leadership presence and people development, mentoring and coaching team members, representing the team professionally in internal and external/vendor forums, and maintaining resilience under pressure.
• Continuous improvement mindset, proactively identifying ways to improve quality, efficiency, and transparency in ways of working, tools, and governance.
• Ability to drive adoption of standardized ways of working, engaging cross-functional partners to support consistent use.

Enterprise Leadership Skills

• Influence: Involve others in exploring solutions—Ask for others’ ideas and build on them to reach a mutually agreeable solution; seek and respect alternative approaches and conflicting viewpoints to identify points of agreement.
• Business Savviness: Analyze—Use organization and industry information to identify trends, assess current business practices and results, and/or evaluate specific function/operation changes and anticipate their impact.
• Networking and Partnerships: Seek opportunities to build relationships—Proactively build effective working relationships with those who have the knowledge, experience, resources or influence to advance work goals.

Qualifications & experience

• Associate’s degree and a minimum of 15 years’ clinical data management or standards experience (or related discipline)
• OR
• Bachelor’s Degree and minimum of 8 years’ clinical data management or standards experience
• OR
• Advanced Degree (Masters or Doctorate) and minimum of 4 years’ clinical data management or standards experience

US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The primary location for this posting is: USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is: $142,400.00 - $224,100.00. This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

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.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Not Applicable
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): n/a
Job Posting End Date: 11/7/2026
*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.