Associate Specialist, Clinical Data Management

Merck Merck · Pharma · NJ

This role focuses on clinical data management and programming within the healthcare domain, utilizing platforms like Oracle and Veeva, and external data sources. Responsibilities include designing, building, maintaining, testing, and documenting data review processes, supporting data cleaning and reporting for clinical studies, and performing ongoing support for in-life reports. The role requires technical proficiency in data management systems and programming languages, along with knowledge of SDLC, validation, and regulatory guidelines (FDA, GxP, ICH).

What you'd actually do

  1. Assumes the responsibilities for all clinical programming (including reporting and analytics) deliverables including Oracle, Veeva platforms along with the external data captured in support of the clinical studies.
  2. Coordinates and participates in the following activities:
  3. Design, build, maintain, test, and document data review based on written specifications established by Global Clinical Data Management, Clinical Research and Global Safety. Review the technical feasibility of study team proposed programming/reporting and technically implements them. Work effectively among team to communicate issues and ideas to improve the business along with understanding of Protocol .
  4. Support the development & reporting for data cleaning, medical review, clinical monitoring, and safety reports for quality and timely availability in support of our customer needs.
  5. Perform ongoing support for In-Life Reports. Change Requests and Incident Reports are fully documented, signed off, tracked, and reported to upper management.

Skills

Required

  • Adaptability
  • Analytical Problem Solving
  • Clinical Data Cleaning
  • Clinical Data Management
  • Clinical Medicine
  • Clinical Physiology
  • Clinical Reporting
  • Clinical Research
  • Computer Science
  • Data Analysis
  • Data Documentation
  • Data Entry
  • Data Processing
  • Data Reporting
  • Data Review
  • Data Validation
  • Data Visualization
  • Drug Discovery Process
  • FDA Regulations
  • Good Clinical Practice (GCP)
  • Medical Review
  • Nephrology
  • Pathophysiology
  • Root Cause Analysis (RCA)

What the JD emphasized

  • Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH