Merck
Job Description
Leads and executes clinical database development and programming activities across multiple clinical programs. Ensures delivery of high-quality, compliant, and timely clinical database solutions aligned with established standards and study requirements.
Acts as a technical SME supporting study teams, cross-functional partners, and vendors. Contributes to database design, development, validation, and integration activities, while driving continuous improvement, operational efficiency, and consistency across Clinical Data processes.
Key Responsibilities:
Clinical Database Delivery & Execution (40%)
Oversees and coordinates clinical database activities across multiple clinical programs
Interfaces with CDS leadership to ensure consistency of technical strategies and execution
Plans and manages timelines to ensure on-time delivery of database-related activities
Collaborates with study teams, stakeholders, and vendors to translate requirements into deliverables
Database Development & Programming (20%)
Designs, develops, and maintains clinical databases and data transfer files according to specifications
Programs and validates edit checks, derivations, and scripts supporting data ingestion and integration
Leads and participates in review of eCRFs, edit checks, and database build activities
Ensures adherence to standards, SOPs, and process guidelines
Training, Mentorship & SME Support (20%)
Trains new hires and supports ongoing capability development across the team
Acts as a subject matter expert for troubleshooting, issue resolution, and best practices
Promotes a high-quality, customer-focused, and collaborative working environment
Innovation, Process Improvement & Digital Enablement (15%)
Leads and participates in task forces, system evaluations, and CDS technical initiatives
Contributes innovative solutions to enhance processes and increase productivity
Supports the evaluation and adoption of improved ways of working, including appropriate use of automation and data-driven approaches
Demonstrates awareness of emerging digital capabilities (e.g., automation, advanced analytics, AI-enabled tools) and explores their applicability to improve efficiency and consistency
Planning & Coordination (5%)
Supports project planning, resource forecasting, and workload distribution across therapy areas
Aligns with CDS leadership to ensure consistency of approach across programs
Qualifications, Skills & Experience
Experience
7-10 years of clinical database development and/or data programming experience
Strong experience with clinical data management systems (e.g., Inform, Architect, Central Designer)
Experience with Oracle databases and SQL/PL-SQL
Experience working in regulated clinical development environments
Technical & Functional Skills
Strong understanding of clinical database design, eCRFs, edit checks, and data validation
Experience in programming data logic, integration workflows, and data transfer processes
Knowledge of clinical data standards, regulatory requirements, and GxP/ICH guidelines
Familiarity with end-to-end clinical data lifecycle and data cleaning processes
Exposure to tools and approaches supporting automation, data workflows, and process optimization
Digital & Innovation Capabilities
Demonstrated awareness of emerging digital capabilities, including automation and AI, and their potential application within clinical data management
Ability to identify opportunities to improve processes using data-driven and automation approaches, while ensuring compliance within regulated environments
Core Skills
Strong problem-solving and analytical thinking skills
Effective communication and ability to present technical concepts clearly
Strong collaboration and stakeholder engagement skills
Ability to work independently and manage multiple priorities
Strong attention to detail and commitment to quality and compliance
Willingness to learn and adopt new processes and technologies
Required Skills:
Adaptability, Adaptability, Automation, Clinical Database Programming, Clinical Databases, Clinical Data Management, Clinical Development, Clinical Informatics, Clinical Trials, Data Analysis, Data Cleansing, Data Extraction, Data Integration, Data Validation, Decision Making, Good Clinical Practice (GCP), Interpersonal Relationships, Operational Efficiency, Oracle Database, People Leadership, Pharmacovigilance, PL/SQL (Programming Language), Project Planning, Proven Commitment, Regulatory Compliance {+ 2 more}
Required Skills:
Adaptability, Adaptability, Clinical Database Programming, Clinical Databases, Clinical Data Management, Clinical Data Standards, Clinical Development, Clinical Informatics, Computer Science, Data Analysis, Data Integration, Data Quality Assurance, Data Reporting, Data Validation, Detail-Oriented, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Interpersonal Relationships, Mentoring Staff, Mentorship, Operational Efficiency, Oracle Database, Project Management Tools, Project Planning, Regulatory Compliance {+ 1 more}
Preferred Skills:
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Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
07/15/2026
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