Sr. Scientist, Clinical Operations

Merck Merck · Pharma · NJ

Senior Scientist role focused on leading the scientific planning and execution of clinical trials in Ophthalmology/Retina, involving medical monitoring, data interpretation, and cross-functional collaboration within a global team. Requires strong knowledge of clinical research regulatory requirements (GCP, ICH) and analytical skills.

What you'd actually do

  1. Serving as the lead clinical scientist on the clinical trial team.
  2. Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director.
  3. Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents/amendments); Partners with the Study Manager on study deliverables.
  4. Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
  5. Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.

Skills

Required

  • Adaptability
  • Clinical Data
  • Clinical Data Interpretation
  • Clinical Operations
  • Clinical Quality Assurance
  • Clinical Research
  • Clinical Study Design
  • Clinical Trial Compliance
  • Clinical Trial Management
  • Clinical Trials
  • Conflict Resolution
  • Critical Thinking
  • Cross-Functional Collaboration
  • Data Analysis
  • Drug Development
  • Ethical Standards
  • ICH GCP Guidelines
  • Life Science
  • Medical Writing
  • Motivation Management
  • Prioritization
  • Problem Solving
  • Regulatory Compliance
  • Regulatory Documents
  • Scientific Publications

What the JD emphasized

  • Ophthalmology/Retina related experience required
  • Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)