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
- Interface with study teams and stakeholders to integrate requirements into deliverables
- Align with CDS leadership on technical strategies and execution
- Lead/participate in improvement initiatives (task forces, automations, emerging digital capabilities such as advanced analytics and AI)
- Contribute strategies to enhance processes and productivity using automation and data-driven approaches
- Support testing/evaluation of new systems, tools, and capabilities
- Coordinate CDS technical initiatives to improve efficiency and scalability
- Serve as SME for clinical database and EDC activities (database development and data integration)
- Provide technical guidance, best practices, and knowledge sharing
- Provide oversight/guidance to Clinical Database Developers
- Support recruitment, onboarding, mentoring, and technical development; contribute to performance input and capability planning
- Lead/contribute to functional and cross-functional meetings; communicate processes, requirements, and risks to stakeholders/vendors
Qualifications:
- Required: Bachelorβs in Computer Science (or related) or equivalent experience; 5+ years in pharmaceutical clinical research/data management; experience with clinical database development, EDC systems, and data management; strong clinical database/eCRF/edit check understanding; knowledge of EDC/data management systems; familiarity with clinical data standards, regulatory requirements, and GxP/ICH; understanding end-to-end clinical data lifecycle and data cleaning; strong stakeholder management; effective communication; strong organizational/project management; independent work with competing priorities; high attention to detail/compliance
- Preferred: Technology implementation/system evaluation experience; exposure to automation/data workflows/process optimization; awareness of emerging digital capabilities (automation/AI) in clinical data management; ability to improve processes while ensuring compliance
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.