Associate Specialist, Clinical Data Management, Hybrid

Assumes responsibilities for clinical programming deliverables (reporting/analytics) including Oracle and Veeva platforms, and external data supporting clinical studies.

Responsibilities
- Design, build, maintain, test, and document data review per specifications (GCDM, CR, GS). Assess technical feasibility of study team programming/reporting requests and implement them.
- Support development and reporting for data cleaning, medical review, clinical monitoring, and safety reports.
- Provide ongoing support for In-Life Reports; ensure Change Requests and Incident Reports are fully documented, signed off, tracked, and reported to upper management.
- Participate in study improvement task forces, automations/initiatives, testing new systems, and training/mentoring.

Education
- B.A. or B.S. in math, science, healthcare discipline, or computer science; or relevant Pharma skills/experience.

Qualifications / Knowledge & Skills
- Proficiency in clinical data management/reporting tools (e.g., PowerBI, SQL/PL SQL, Databricks, Python, SAS, plus AI tools).
- MS Windows/Office and web application exposure; SDLC/system validation knowledge.
- Strong communication, organizational/problem-solving skills; ability to work with cross-functional teams; urgency and customer focus.
- Understanding of drug discovery, FDA regulations, GxP, ICH.

Required Skills
- Adaptability, analytical problem solving, clinical data management, data analysis, FDA regulations, GCP, multitasking, SDLC, teamwork, working independently.

Preferred Skills
- Clinical studies, group problem solving, Java, science.

Application
- Apply at https://jobs.merck.com/us/en (deadline stated on posting).