Associate Specialist, Clinical Data Management
Merck
2 months ago
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Primary activities
- Assume responsibilities for all clinical programming (reporting/analytics) deliverables, including Oracle and Veeva platforms and external data supporting clinical studies.
Coordinates And Participates In The Following Activities
- Design, build, maintain, test, and document data review per specifications from Global Clinical Data Management, Clinical Research, and Global Safety; validate technical feasibility of study team programming/reporting and implement.
- Support development/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 task forces, automations, initiatives, testing new systems, and training/mentoring.
Education
- B.A. or B.S. degree (preferred: mathematics, science, healthcare-related discipline, or computer science) or relevant pharma skills/experience.
Knowledge And Skills
- Proficiency with clinical data management/reporting systems (e.g., PowerBI, SQL/PLSQL, Databricks, Python, SAS) and AI-related tools.
- MS Windows/Office; exposure to web-based applications.
- System Development Lifecycle / system validation knowledge.
- Strong communication, organizational, and problem-solving skills; customer focus and urgency.
- Understanding of drug discovery, FDA regulations, GxP, and ICH.
Required Skills
- Adaptability; analytical problem solving; clinical data cleaning/management; clinical reporting/research; data analysis/documentation/validation/visualization; drug discovery process; FDA regulations; GCP; medical review; RCA (and related clinical areas).
Application
- Apply via https://jobs.merck.com/us/en (deadline stated on the posting).
- Assume responsibilities for all clinical programming (reporting/analytics) deliverables, including Oracle and Veeva platforms and external data supporting clinical studies.
Coordinates And Participates In The Following Activities
- Design, build, maintain, test, and document data review per specifications from Global Clinical Data Management, Clinical Research, and Global Safety; validate technical feasibility of study team programming/reporting and implement.
- Support development/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 task forces, automations, initiatives, testing new systems, and training/mentoring.
Education
- B.A. or B.S. degree (preferred: mathematics, science, healthcare-related discipline, or computer science) or relevant pharma skills/experience.
Knowledge And Skills
- Proficiency with clinical data management/reporting systems (e.g., PowerBI, SQL/PLSQL, Databricks, Python, SAS) and AI-related tools.
- MS Windows/Office; exposure to web-based applications.
- System Development Lifecycle / system validation knowledge.
- Strong communication, organizational, and problem-solving skills; customer focus and urgency.
- Understanding of drug discovery, FDA regulations, GxP, and ICH.
Required Skills
- Adaptability; analytical problem solving; clinical data cleaning/management; clinical reporting/research; data analysis/documentation/validation/visualization; drug discovery process; FDA regulations; GCP; medical review; RCA (and related clinical areas).
Application
- Apply via https://jobs.merck.com/us/en (deadline stated on the posting).