Associate Director, Clinical Data Management Trial Lead

MSD; Rahway (NJ); Presencial; USD 142 000 - 224 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical benefits

Retirement plan (401(k))

Paid holidays

Resumo da oferta

MSD Malaysia in Rahway, NJ is seeking a CDM Trial Lead to ensure end-to-end data management across studies, delivering quality, integrity, and compliance with GDMS standards and regulatory requirements. You will lead data collection design, develop validation and query strategies, supervise data review across sources such as EDC, eCOA, labs, and imaging, and mentor CDMs and external specialists.

Strong CDISC knowledge and RBQM are essential to success in this global role.

Qualificações

• Minimum 8–10 years of directly relevant experience in data management or clinical trial operations.
• Advanced degree preferred in Life Sciences, Nursing, Pharmacy, or Data/IT.
• Strong knowledge of CDISC standards (CDASH/SDTM/Define-XML) and regulatory requirements.
• Experience with RBQM, privacy rules, and 21 CFR Part 11 compliance.

Responsabilidades

• Lead end-to-end data management activities from study start-up through database lock and archival.
• Develop data validation and query strategies for sites and vendors across multiple data types (EDC, eCOA, labs, imaging).
• Oversee data integration from diverse sources and ensure data integrity and traceability.
• Mentor and train Clinical Data Managers (CDMs) and External Data Specialists (EDS) and drive knowledge sharing.

Conhecimentos

Clinical Data Management

Influencing Skills

Interpersonal Relationships

Project Leadership

Risk Management

Strategic Thinking

Team Organization

Formação académica

Bachelor's degree or higher in Life Sciences / IT / Medical Technology

Descrição da oferta de emprego

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 strategically 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 own 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

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.

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.

Other Details

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.

Company Culture

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Equal Employment Opportunity

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. Learn more about your rights, including under California, Colorado and other US State Acts.