Associate Director, Clinical Data Management Trial Lead

Merck & Co.; West Point (PA); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck & Co. seeks an experienced CDM Trial Lead to drive end-to-end data management for assigned studies. You will coordinate data collection, validation, and queries across diverse data sources, ensuring compliance with ICH-GCP and regulatory standards.

Lead cross-functional teams, mentor staff, and promote data integrity and inspection readiness. You will partner with site monitoring, medical monitoring, and governance bodies to optimize CDMS processes and deliver timely, quality data for

Qualifications

• Requires extensive experience in data management for clinical trials.
• Knowledge of CDISC standards (SDTM, CDASH, Define-XML) and data standards.
• Strong project leadership and regulatory/compliance understanding.

Responsibilities

• Lead end-to-end data management for studies from start-up to database lock.
• Oversee data collection design, data validation, and query strategy.
• Manage cross-functional data interfaces and vendor interactions.
• Ensure risk-based quality oversight and inspection readiness.
• Oversee UAT and change control across study lifecycle.

Skills

Clinical data management

Project leadership

Risk management

CDISC standards

Fluent English

Education

Bachelor's degree in Life sciences or related field

Advanced degree (MS/PhD)

Tools

EDC systems

eCOA

Define-XML

Job description

Job Description

Under the direction of Therapeutic Area (TA) leadership, the CDM (Clinical Data Management) Trial Lead is accountable for end-to-end delivery of data management activities for assigned studies, ensuring quality, integrity, and compliance with GDMS standards and regulatory requirements. The role provides strategic and operational oversight across the trial lifecycle, serves as the primary data management contact for cross-functional teams, and contributes to process improvement and capability development within the global GDMS community.

Responsibilities

• Lead end-to-end clinical data management activities for assigned studies from study start-up through database lock and archival in accordance with defined processes, timelines, quality targets, Standard Operating Procedures (SOPs), International Council for Harmonization - Good Clinical Practice (ICH-GCP), and protocol-specific requirements; partner with assigned leadership for alignment on strategy, risks, and escalations.
• Oversee clinical data collection design and review across all data types-defined as reconciliation, logical consistency review, and remediation of study data from multiple sources and data types. Responsible for ensuring that study protocol is effectively translated into data management deliverables and tools. Develop data validation and query strategy for execution to clinical sites and service providers through resolution in collaboration and alignment with Site Monitoring and Medical Monitoring, ensuring timely closure and documented rationale.
• Oversee team reviewing, validating, and reconciling data within and across clinical trial data sources and environments, which may include (but not limited to) digital health technologies (DHT), electronic clinical outcome assessments (eCOA), electronic external data (e.g., central laboratories, imaging, biomarkers), vendor/service provider portals, and the clinical database including site entered or transferred data (e.g., EDC [electronic data capture] or DDC [Direct Data Capture]), with accountability for end-to-end integrity across sources and documented rationale for resolution decisions.
• Own risk-based data quality oversight for assigned studies; identify systemic trends and operational risks, accountable cross-source root-cause analysis, implement mitigation plans, and elevate therapeutically with clear options and impact to protect timelines, quality, and inspection readiness.
• Responsible for overseeing data acquisition and integration activities, including data acquisition tool configuration/design inputs, end-to-end data flow validation, and development/maintenance of data integration and/or data cleaning validation specification, in alignment with the protocol, regulations leveraging industry and company standards.
• Ensure specimen and specialty data strategy and operating model are integrated into the trial's end-to-end data approach; oversee delivery expectations across vendors/partners.
• Ensure protocol-aligned laboratory data setup and oversight, including confirmation that laboratories apply protocol-appropriate normal ranges; ensure documentation and supporting evidence are complete and filed within the study record.
• Oversee the development, review, approval, execution, and maintenance of core data management deliverables, including (as applicable) the Data Management Plan (DMP), Data Validation Plan (DVP), electronic case report forms (eCRFs), specifications, User Acceptance Testing (UAT) documentation, medical coding plans, database lock documentation, and archival readiness documentation to ensure protocol fit, compliance, and inspection readiness, aligned to Trial Master File (TMF) expectations.
• Accountable for User Acceptance Testing (UAT) and owned change control activities across the study lifecycle for relevant systems, tools, and data flows, ensuring requirements, test evidence, approvals, and traceability are complete.
• Ensure the implementation of data standards (as applicable), including Clinical Data Interchange Standards Consortium (CDISC) standards (e.g., Study Data Tabulation Model (SDTM), Clinical Data Acquisition Standards Harmonization (CDASH)) and controlled terminology, contributing to mapping/specification development and end-to-end traceability across sources.
• Ensure clinical data management activities comply with privacy and company policies, Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11), and applicable sponsor and health authority regulations and standards, supporting data quality and inspection readiness.
• Actively represent data management on the Clinical Trial Team (CTT) and in governance forums, ensuring effective input into decision-making from protocol design through central data monitoring and analysis; guide cross-functional execution, decision-making, and issue escalation.
• Provide oversight, mentoring, and training to Clinical Data Managers (CDMs) and External Data Specialists (EDS). Foster a culture of knowledge sharing and capability building. Facilitate complex functional and cross functional meetings resulting in documented decisions and action plans.
• For trials originating from acquisitions, partnerships, or outside standard processes, plan and oversee end-to-end data management while ensuring compliance, quality, and inspection readiness; liaise with partner organizations, service providers, and governance bodies, documenting decisions and ensuring compliant processes and tools even when operating models differ from in-house approaches.
• Contribute expertise, project management, and/or leadership to additional projects and continuous improvement initiatives, including (but not limited to) process, standards, and platform / tool efforts.

Technical Skills

• Deep understanding of the clinical development lifecycle, data flow, and cross-functional dependencies (e.g., Clinical Operations, Biostatistics, Safety, Data Standards, and Regulatory).
• Strong command of clinical data management platforms and enabling technologies, including electronic data capture (EDC) systems and other data acquisition tools (e.g. eCOA), query management, data reconciliation/integration, and data visualization/dashboarding tools.
• Extensive experience designing, validating, and maintaining integrated data management deliverables and validation components to ensure accuracy, auditability, and compliance.
• Demonstrated Understanding of Clinical Data Interchange Standards Consortium (CDISC) standards (e.g., Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Model (SDTM), Define-XML), metadata management, and controlled terminologies to ensure data consistency and submission readiness.
• Quality, compliance, and risk orientation with working knowledge of Standard Operating Procedures (SOPs), International Council for Harmonization - Good Clinical Practice (ICH-GCP), Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) and Annex 11, and privacy requirements; apply risk-based, data-driven approaches (e.g., Risk-Based Quality Management (RBQM)) to prevent or mitigate issues.
• Solid foundation in clinical practice and medical terminology, supporting effective data interpretation and timely issue resolution.

Non-technical Skills

• Effective Project Manager that excels at planning, execution and risk management including identification of Critical to Quality factors related to data management. Sets priorities across teams and workstreams; drives alignment to organizational priorities and delivery commitments.
• Effectively facilitates cross functional discussions to ensure robust and timely decisions.
• Fluent in English with exceptional communication and influencing skills across functions, geographies, and organizational levels; clearly conveys complex topics to diverse audiences.
• Strong stakeholder management and collaboration; builds trust and effective partnerships to deliver consistent, high-quality outcomes.
• Independent and accountable work style; leads through influence and maintains alignment with leadership direction and strategy.
• Effective facilitator of decision-making; coordinates the work of others and drives timely resolution of complex issues.
• Builds and scales capability through mentoring, coaching, and knowledge-sharing; motivates and guides teams without direct authority.
• High adaptability and resilience; performs effectively under pressure in fast-changing environments while maintaining alignment.

Enterprise Leadership Skills

• Networking & Partnerships - Builds and maintains effective working relationships across teams and functions to access the knowledge, experience, resources, and influence needed to support team success and advance work goals.
• Executional Excellence - Focuses on delivering results in accordance with compliance standards by setting clear priorities, aligning others on the most critical work, monitoring progress, and ensuring accountability for outcomes.
• Influence - Uses effective involvement and persuasion strategies to build alignment and gain commitment to actions that support team success and advance work outcomes.

Qualifications & Experience

• Non-Degree or associate's degree (preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology) with minimum 10 years of directly relevant experience working in data management, clinical trial operations or related field.

OR

• Bachelor's Degree (preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology; or equivalent education experience) with minimum 8 years of experience working in data management, clinical trial operations or related field.

OR

• Advanced Degree (Masters or Doctorate) (preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology) with minimum 4 years of experience working in data management, clinical trial operations or related field.

Required Skills

Clinical Data Management, Influencing Skills, Interpersonal Relationships, Project Leadership, Risk Management, Strategic Thinking, Team Organization

Preferred Skills

Clinical Research, Mentoring Staff, Prioritization, Project Management Tools

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.

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 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.

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Salary

The salary range for this role is $142,400.00 - $224,100.00

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.

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

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

No

Job Posting End Date

10/16/2026

*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

R421780