Merck
USA New Jersey Rahway, NJ
Shift: Full time
Job Description We aspire to be the premier research-intensive biopharmaceutical company. We re at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and contribute to our mission of using the power of leading-edge science to save and improve lives around the world. Responsibilities Oversee and coordinate clinical database activities across multiple clinical programs, including review of eCRFs, edit check specifications, and database development Ensure adherence to clinical database standards, SOPs, and process guidelines Plan and manage timelines for database deliverables; identify and escalate risks appropriately Interface with study teams and stakeholders to integrate requirements into deliverables Align with CDS leadership to ensure consistency of technical strategies and execution Lead and participate in improvement initiatives, including task forces, automations, and exploration of emerging digital capabilities (e.g., advanced analytics, AI-enabled tools) Contribute strategies and innovative solutions to enhance processes and increase productivity, including the appropriate use of automation and data-driven approaches Support testing and evaluation of new systems, tools, and capabilities Coordinate and contribute to CDS technical initiatives that improve efficiency and scalability Serve as subject matter expert (SME) in clinical database and EDC activities, including database development and data integration Increase functional effectiveness by supporting efforts to simplify and standardize processes, including identifying opportunities for automation and improved data workflows Provide technical guidance, best practices, and knowledge sharing across the team and broader organization Provide oversight and guidance to Clinical Database Developers Support recruitment, onboarding, mentoring, and technical development of team members Contribute to performance management input and capability development planning Lead or contribute to functional and cross-functional meetings Communicate clinical database processes, requirements, and risks effectively to stakeholders and vendors Support alignment, decision-making, and continuous improvement efforts Qualifications Required Bachelor’s degree in Computer Science or related discipline (or equivalent experience) Minimum of 5 years of experience in pharmaceutical clinical research / data management Experience in clinical database development, EDC systems, and data management processes Strong understanding of clinical database design, eCRFs, edit checks, and data collection frameworks Knowledge of EDC and data management systems Familiarity with clinical data standards, regulatory requirements, and GxP/ICH guidelines Understanding of end-to-end clinical data lifecycle and data cleaning processes Strong stakeholder management and cross-functional collaboration skills Effective communication and ability to translate technical concepts clearly Strong organizational, prioritization, and multi-project management skills Ability to work independently and manage competing priorities High attention to detail and commitment to quality and compliance Preferred Experience in technology implementation and/or system evaluation Exposure to automation tools, data workflows, and process optimization approaches 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 Required Skills: Adaptability, Adaptability, Artificial Intelligence (AI), Automation, Clinical Database Programming, Clinical Data Management, Clinical Data Standards, Clinical Development, Clinical Trials Operations, Data Analysis, Data Engineering, Data Quality Assurance, Data Reporting, Data Validation, Detail-Oriented, Drug Discovery Process, Escalation Management, FDA Regulations, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Integration Architecture, Interpersonal Relationships, Mentoring Staff, Project Management Tools, Release Management {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE 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. Please click here if you need an accommodation during the application or hiring process. 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.