GDMS/GCTO

policies and enterprise digital / data initiatives. Own development of critical capabilities (tools, processes, skills) aligned to business needs and industry best practices. Establish capability governance aligned with

GDMS/GCTO

policies and enterprise digital/data initiatives. Drive consistent global rollout via playbooks, guidance, and implementation support; align cross-regional ways of working with partners. Technical skills Deep experience leading end-to-end data management for clinical trials, including database design/build/UAT (User Acceptance Training), edit checks/validation, review/reconciliation, database lock, and the design, validation, and maintenance of DM (Data Management) deliverables using relevant Clinical Data Manager platforms and enabling technologies. Deep understanding of data structures and integrations across EDC (Electronic Data Capture) and connected systems (e.g., labs, IRT [Interactive Response Technology], eCOA [electronic Clinical Outcome Assessment], imaging), with a demonstrated ability to triage and resolve complex study-level issues to maintain data integrity across internal systems and service providers. Advanced knowledge across two or more Therapeutic Areas, applying TA-specific scientific and operational expertise to shape indication- and TA-level data management strategy, planning, resource allocation, and execution. Comprehensive knowledge of the clinical development lifecycle, data flow, and cross-functional dependencies (Clinical Operations, Biostatistics, Safety, Data Standards, Regulatory), supported by a deep understanding of clinical practice and medical terminology. Advanced proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards (CDASH [Clinical Data Acquisition Standards Harmonization], SDTM [Study Data Tabulation Model], Define-XML), metadata management, and controlled terminologies (e.g., LOINC [Logical Observation Identifiers Names and Codes]) to ensure consistency and submission readiness. Working knowledge of SOPs (Standard Operating Procedures), ICH-GCP (International Council for Harmonization - Good Clinical Practice), 21 CFR Part 11/Annex 11, and privacy expectations, applying risk-based, data-driven approaches (RBQM [Risk Based Quality Management]) to prevent or mitigate issues. Non-technical skills Strategic leadership with the ability to align different teams and stakeholders around shared TA objectives. Strong people leadership, mentoring, and development capabilities across multiple levels and geographies. Advanced stakeholder management and negotiation skills across functions and seniority levels. Ability to lead change, embed innovation, and drive continuous improvement initiatives. Resilient and adaptable, with a balance of strategic vision and operational execution. Ability to integrate business, operational, and people dimensions to effective decision-making. Enterprise Leadership Skills Networking & Partnerships | Develops and maintains strategic relationships with internal and external stakeholders to bring forward the information, perspectives, expertise, and influence needed to address issues and advance organizational goals. Coaching & Development | Provides feedback, guidance, and development support to help others excel in current and future roles, while actively building the skills and capabilities needed for individual and organizational success of Clinical Data Manager. Strategic Planning | Identifies and evaluates the key issues, trends, and cross-functional interdependencies most relevant to long-range goals. Uses facts, assumptions, resource constraints, and organizational priorities to define an effective path forward that supports the long-term success of the Clinical Data Manager organization. Qualifications & experience Bachelors of Arts or Science in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology with 13 years of experience in clinical data management, clinical trial operations or related field, including 5 years of people management experience. Demonstrate deep SME (Subject Matter Expert) in relevant discipline. OR Bachelors of Arts or Science (or equivalent educational experience) in any field not listed above with 18 years of experience in clinical data management, clinical trial operations or related field, including 5 years of people management experience. Demonstrate deep SME (Subject Matter Expert) in relevant discipline. OR Advanced Degree (preferred) (Masters or Doctorate) in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology with 10 years of experience in clinical data management, clinical trial operations or related field, including 5 years of people management experience. Demonstrate deep SME in relevant discipline. OR Advanced Degree (preferred) (Masters or Doctorate) in any field not listed above with 15 years of experience in clinical data management, clinical trial operations or related field, including 5 years of people management experience. Demonstrate deep SME in relevant discipline. AND Demonstrated experience in leading geographically different cross functional teams in delivery of clinical data management or clinical trial operations strategy, execution and submissions (Inspections & Health Authority Interactions & Responses). clinicaltrialjobs

Required Skills:

Change Management, Clinical Data Standards, Clinical Trials Operations, Cross-Functional Teamwork, Data Governance, Decision Making, Ethical Standards, Good Clinical Practice (GCP),

Oncology, People Leadership, Stakeholder Relationship Management, Strategic Planning Preferred Skills:

Adaptability, Operational Execution, Strategic Thinking Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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: EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA

Supplement 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. Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/) The salary range for this role is $173,200.00 - $272,600.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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 . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

No Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid Shift:

1st -

Day Valid Driving License:

No Hazardous Material(s):

N/A Job Posting End Date:

08/21/2026 •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.

Requisition ID:

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