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-enabled tools)
- Contribute strategies to enhance processes and increase productivity using automation and data-driven approaches
- Support testing/evaluation of new systems, tools, and capabilities
- Coordinate/contribute to 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; oversee Clinical Database Developers
- Support recruitment, onboarding, mentoring, and technical development; contribute to performance management input
- Lead or contribute to functional/cross-functional meetings; communicate processes/requirements/risks to stakeholders and vendors
Qualifications:
- Bachelorβs degree 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 processes
- Strong clinical database design knowledge (eCRFs, edit checks, data collection frameworks)
- Knowledge of EDC/data management systems; familiarity with clinical data standards, regulatory requirements, and GxP/ICH; end-to-end lifecycle and data cleaning
- Strong stakeholder management, cross-functional collaboration, communication, organization, prioritization, and compliance
Preferred:
- Technology implementation/system evaluation; automation tools and process optimization
- Awareness of emerging digital capabilities (automation/AI) and applying them compliantly
Required Skills (high level):
- Clinical data management/standards/quality, data analysis/engineering/reporting/validation, automation, AI, programming, GCP/GCDMP, FDA regulations, escalation management, integration architecture, project/release management, mentoring.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).