Director, Clinical Data Management, Digital Health Technologies, Hybrid

Merck•North Wales, PA

2d•$173,200 - $272,600•Hybrid

About The Position

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.

Requirements

Bachelor's Degree or higher preferably in Medicine, Pharmacy, Nursing, Biological Sciences, Health Care, Computer Science or Engineering related discipline
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
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.
Excellent oral and written communications skills - able to present information confidentially and effectively to leadership, peers, and team.
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

Nice To Haves

Deliverables Management
Generative AI
Standard Operating Procedure (SOP)

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.