Primary Responsibilities:
- Design, build, maintain, test, and document data review based on written specifications.
- Review technical feasibility of study-team proposed programming/reporting and technically implement; collaborate across teams and communicate issues/ideas while understanding protocol.
- Support development and reporting for data cleaning, medical review, clinical monitoring, and safety reports for quality and timely availability.
- Provide ongoing support for In-Life Reports.
- Ensure Change Requests and Incident Reports are documented, signed off, tracked, and reported to upper management.
- Participate in study improvement initiatives (e.g., automation), testing of new systems, and ongoing training/mentoring.
Education:
- Associate degree + 3+ years in clinical data programming/data engineering or related functions, OR
- Bachelorβs degree + 2+ years in related clinical data programming/data engineering/clinical operations functions, OR
- Advanced degree preferred (masterβs/doctorate) with experience in clinical development and/or related activities.
Required Knowledge & Skills:
- Proficiency in clinical data/reporting systems (e.g., Databricks, Python, SAS, SQL/PL/SQL, Power BI) and AI tools.
- MS Windows/Office knowledge; exposure to web-based applications.
- System Development Lifecycle Management/system validation knowledge.
- Strong relationships, urgency/customer focus, communication with study teams, organization/problem-solving, ability to learn, multitask and work independently.
- Understanding of drug discovery process, FDA regulations, GxP, and ICH.
Required Skills (examples): Clinical Data Management, Communication, Programming, Data Analysis/Quality Assurance, EDC, PL/SQL, SQL databases, team communication.
Benefits (explicitly stated): comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.