Associate Director, Clinical Data Management...

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)

Bachelor’s Degree and minimum of 8 years’ clinical data management or standards experience

Advanced Degree (Masters or Doctorate) and minimum of 4 years’ clinical data management or standards experience

#GDMS

clinicaltrialjobs

eligibleforERP

Required Skills:

Adaptability, Adaptability, Building Capability, Clinical Database Programming, Clinical Data Management, Clinical Data Standards, Coaching, Competency Management, Compliance Activities, Data Analysis, Data Management, Data Quality Assurance, Data Reporting, Data Validation, Detail-Oriented, Enterprise Leadership, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Implement Training Programs, Interpersonal Relationships, Mentoring Staff, Operational Quality, Prioritization, Process Improvements, Process Standardization {+ 9 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description

Associate Director, Clinical Data Management

The Associate Director, responsible for data collection governance, GDMS GCDS, provides program-level oversight of data standards, guides study teams in the use of libraries and first-line governance, and advances new or modified standards as well as operational processes. The person leads the Therapeutic Area Standards Teams (TAST) and training activities, supports information governance, tracks compliance and benefits achieved, and mentors less experienced staff.

Responsibilities

Define and maintain standardized data collection definitions, both for electronic data capture (EDC [Electronic Data Capture]) and for other modalities, in compliance with industry standards (e.g., CDISC [Clinical Data Interchange Standards Consortium]) as well as regulations and guidelines of health authorities; ensure their harmonization throughout the clinical lifecycle (collection, analysis and reporting, and regulatory submission).
Participate in and lead organizational initiatives, as needed.
Support audits and inspections, as needed.
Support the information governance reviews assigned to them (e.g., triage, impact assessment, curation, and stakeholder feedback/continuous improvement) through the TAST (Therapeutic Area Standards Teams) and SLIC (Shared Clinical Data Standards Council) governance teams.
Develop and deliver standards training and best practices to cross-functional teams.
Participate in the development and delivery of training, and in mentoring members of the global clinical data standards team.
Participate in industry forums, maintain a network of contacts, and influence the strategic direction of the industry as well as the development of clinical data standards. Identify trends related to technological advances, changes in industry standards and regulatory requirements, and determine their impact on the implementation of our company's standards.
Act as a reliable partner to GDMS and other cross-functional teams by actively seeking their feedback, aligning priorities, and closing feedback loops to ensure coordinated, high-quality delivery.
Provide oversight and expertise to staff, within one or more therapeutic areas (TA [Therapeutic Areas]), regarding data collection and transformation design as well as data modeling, ensuring compliance with established standards guidelines.
Sit on the core design team for the studies assigned to them and provide first-line governance support for changes to existing library forms and the addition of new content.
Support the development of future standards libraries, including in new therapeutic areas, as well as the review of existing processes described in standard operating procedures (SOP [Standard Operating Procedures]), work instructions (WI [Work Instructions]), etc., ensuring their compliance with quality requirements.
Participate in the operational forums and study team forums assigned to them, ensuring that clinical data standards comply with industry standards, our company's standards and processes, and information management best practices.
Support the definition and updating of the operational processes of the data collection functional area and of related technologies used to define, maintain, apply, and share clinical data standards.

Technical skills

Expertise in the development and implementation of clinical data standards.
In-depth knowledge of and experience applying CDISC standards for clinical study data (e.g., CDASH [Clinical Data Acquisition Standards Harmonization], controlled terminology, and SDTM [Study Data Tabulation Model]).
In-depth understanding of and experience with clinical development trial processes, including data management and global regulatory requirements for data management (DM [Data Management]) and reporting.
Demonstrated understanding of program-level clinical and business requirements and of the impact of standards.
Strong knowledge of the drug discovery process, ICH (International Council for Harmonisation) guidelines, and good clinical practice (GCP [Good Clinical Practice]).
Demonstrated knowledge of at least one therapeutic area and ability to promote consistency across all studies in a clinical development program and/or therapeutic area.
Knowledge of analysis and reporting.
Expertise in electronic data capture and in data from external suppliers.
Ability to take an enterprise-wide view of study needs, including controlled terminology, SDTM, analysis and reporting, and regulatory submission objectives and deliverables, in order to ensure appropriate application of standards.
Ability to interpret the study protocol in relation to study design. Ability to interpret protocol requirements to facilitate cross-functional understanding of data types and sources, and then translate them into high-quality, compliant data standard definitions.

Preferred:

Direct experience implementing industry standards (e.g., controlled terminologies, CDISC CDASH, SDTM, ADaM [Analysis Data Model], and HL7 [Health Level Seven International]) and the requirements for analysis, reporting, and submission deliverables (e.g., SDRG [Study Data Reviewer's Guide], ADRG [Analysis Data Reviewer's Guide], and Define.xml).
Experience managing clinical data management processes, including electronic case report form (eCRF [electronic Case Report Form]) design, clinical database development and validation, user acceptance testing, and external data management, as well as knowledge of data transformation to SDTM and of analysis and reporting.
Ability to leverage technical solutions to manage functional and/or project deliverables and the quality associated with the projects assigned to them.

Non-technical knowledge, skills, and abilities

Strong communication and collaboration skills within cross-functional and global teams; ability to prepare concise summaries for leadership that facilitate decision-making and clearly present risks, options, and recommendations.
Strong organization and prioritization skills: manage multiple deliverables, plan various tasks, ensure risk and change control, align stakeholder expectations, including those of suppliers, and provide reliable updates on progress and governance.
Ability to exercise influence-based leadership, to motivate cross-functional teams spread across different regions, to guide and review work, and to foster an inclusive culture based on a high level of trust.
Sound judgment and a sense of accountability; ability to work effectively amid ambiguity, to handle situations requiring escalation, and to contribute to building consensus on process and technology improvements, including root cause analysis (RCA [Root Cause Analysis]) and corrective and preventive actions (CAPA [Corrective and Preventive Action]), where applicable.
Leadership presence and staff development: provide mentorship and coaching to team members, represent the team professionally in internal and external forums or with suppliers, and show resilience under pressure.
Continuous improvement mindset: proactively identify ways to improve the quality, efficiency, and transparency of working methods, tools, and governance.
Ability to promote the adoption of standardized working methods by engaging cross-functional partners to ensure consistent use.

Enterprise leadership skills

Influence: involve others in finding solutions — ask for their ideas and build on them to reach a mutually acceptable solution; seek out and respect different approaches and divergent viewpoints in order to identify points of agreement.
Business acumen: analyze — use information about the organization and the industry to identify trends, assess current practices and results, and/or evaluate specific changes affecting a function or activity and anticipate their impact.
Networking and partnerships: seek opportunities to build relationships — proactively establish effective working relationships with people who have the knowledge, experience, resources, or influence needed to advance work objectives.

Qualifications and experience

Associate’s degree and at least 15 years of experience in clinical data management or clinical data standards, or in a related discipline.

Bachelor’s degree and at least 8 years of experience in clinical data management or clinical data standards.

Advanced degree (Master’s or Doctorate) and at least 4 years of experience in clinical data management or clinical data standards.

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

Search Firm Representatives Please Read Carefully

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:

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

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.

Associate Director, Clinical Data Management

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