Director, Clinical Data Management, Digital Health Technologies, Hybrid

Job Description This leader sits at the intersection of strategy, innovation, and operational excellence, driving the vision for data management across a complex clinical research portfolio. With deep expertise in vendor governance, quality oversight, and organizational leadership, they align teams around ambitious goals, cultivate top talent, and ensure the delivery of high-quality outcomes that advance scientific discovery. Balancing long-term strategic planning with day-to-day execution, they champion continuous improvement, influence key stakeholders, and shape the future of clinical data management through collaboration, innovation, and exceptional leadership. Directs all data management support activities within their functional area. This may include responsibility for clinical research, clinical pharmacology, and epidemiology studies as well as non-project support. Aligns others around a positive direction. Under the guidance of the department head and/or their manager, develops high level, challenging, but achievable objectives that clearly support stated organizational goals. Forecasts short and long term resource needs, establishes measures to improve their area’s effectiveness and efficiency, and develops strategic plans. Expert in vendors oversight and governance. Interfaces with Digital Health Technology (DHT) / Clinical Outcome Assessment (COA) vendors at executive, and tactical levels to deliver our company portfolio with high quality. Develops and tracks key performance indicators (KPIs). Strategizes sourcing refresh and leads vendors onboarding plans & activities. Influences vendor Quality Management System (QMS) to ensure high quality outcomes for stakeholders. Develops career plans for direct reports (some of whom may be at the Associate Director level), makes work assignments, conducts periodic skill assessments as well as annual performance appraisals, coaches for performance, provides ongoing feedback on performance, provides rewards and recognition, and sets priorities. Provides developmental opportunities for employees, through management team or directly, including challenging growth assignments. Develops promotion strategies for their area. Ensures employees receive appropriate training and mentoring to be successful in their assignments. Provides advice and consultation on data management or functional area-specific activities to both internal (e.g., Clinical, Regulatory Affairs, Biostatistics and Research Decision Sciences (BARDS), Human Resources, etc.) and external (e.g., clinical investigators, regulatory agencies, vendors, etc.) clients. Directs staff in the development, implementation, and documentation of standard operating procedures (SOPs) related to their area’s functions to ensure compliance with worldwide regulatory and relevant internal our company’s requirements. May play a key role in the selection of in-house and external data management systems and the determination of work processes. May collaborate with data management groups from other divisions, companies, and agencies to ensure the validity and effectiveness of data management techniques and processes within Global Data Management & Standards (GDMS) Keeps abreast of new developments in the area of clinical data collection, processing, storage and retrieval in order to provide guidance in the selection, enhancement, and maintenance of data management tools and processes. May lead or provide direction to a continuous improvement special project. May support any other project or perform any other data management task deemed appropriate by management. Responsibilities Directs all data management support activities within their functional area. This may include responsibility for clinical research, clinical pharmacology, and epidemiology studies as well as non-project support. Aligns others around a positive direction. Under the guidance of the department head and/or their manager, develops high level, challenging, but achievable objectives that clearly support stated organizational goals. Forecasts short and long term resource needs, establishes measures to improve their area’s effectiveness and efficiency, and develops strategic plans. Expert in vendors oversight and governance. Interfaces with Digital Health Technology (DHT) / Clinical Outcome Assessment (COA) vendors at executive, and tactical levels to deliver our company portfolio with high quality. Develops and tracks key performance indicators (KPIs). Strategizes sourcing refresh and leads vendors onboarding plans & activities. Influences vendor Quality Management System (QMS) to ensure high quality outcomes for stakeholders. Develops career plans for direct reports (some of whom may be at the Associate Director level), makes work assignments, conducts periodic skill assessments as well as annual performance appraisals, coaches for performance, provides ongoing feedback on performance, provides rewards and recognition, and sets priorities. Provides developmental opportunities for employees, through management team or directly, including challenging growth assignments. Develops promotion strategies for their area. Ensures employees receive appropriate training and mentoring to be successful in their assignments. Provides advice and consultation on data management or functional area-specific activities to both internal (e.g., Clinical, Regulatory Affairs, Biostatistics and Research Decision Sciences (BARDS), Human Resources, etc.) and external (e.g., clinical investigators, regulatory agencies, vendors, etc.) clients. Directs staff in the development, implementation, and documentation of standard operating procedures (SOPs) related to their area’s functions to ensure compliance with worldwide regulatory and relevant internal our company’s requirements. May play a key role in the selection of in-house and external data management systems and the determination of work processes. May collaborate with data management groups from other divisions, companies, and agencies to ensure the validity and effectiveness of data management techniques and processes within Global Data Management & Standards (GDMS) Keeps abreast of new developments in the area of clinical data collection, processing, storage and retrieval in order to provide guidance in the selection, enhancement, and maintenance of data management tools and processes. May lead or provide direction to a continuous improvement special project. May support any other project or perform any other data management task deemed appropriate by management. Education Bachelor's Degree or higher preferably in Medicine, Pharmacy, Nursing, Biological Sciences, Health Care, Computer Science or Engineering related discipline Experience 12+ years of experience in Clinical Data Management and/or Clinical Operations (or related industry experience) 5+ years of experience in a management position 5+ years of experience with DHT, COA and/or IRT (Interactive Response Technologies) experience Knowledge And Skills Have solid results and delivery-oriented leadership style with experience in best practice project management methods such as Waterfall and Agile. Broad understanding of drug development -safety, clinical trials, trial design, data management, trial operations, regulatory, privacy, ICH, and GCP required Ability to manage a global and an organization with flexible staff thru 3rd party partners. Experience leading an organization that delivers against pre-established and benchmarked service level standards (quality, timeliness and productivity) for all deliverables and services. Experience working with internal (Clinical Sciences, BARDS, Global Clinical Trial Operations (GCTO), our Research & Development Division IT) and external (functional service providers, labs, investigator sites, etc.) stakeholders to deliver products and services supporting a portfolio of clinical trials/programs across multiple therapeutic areas. Experience leading/sponsoring process and/or technology-based innovation initiatives to maximize delivery of services with measurable outcomes. Must have excellent oral and written communications skills - able to present information confidentially and effectively to leadership, peers, and team. clinicaltrialjobs Required Skills Clinical Data Management, Data Validation, Decision Making, Digital Technology, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), People Leadership, Results-Oriented, Strategic Thinking, Support Management, System Improvements, Vendor Management Preferred Skills Deliverables Management, Generative AI, Standard Operating Procedure (SOP) 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. Requirements 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 Salary 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 Application Deadline 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 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 09/16/2026 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 R416554 #J-18808-Ljbffr Merck