Senior Study Manager, Epidemiology Operations-3

Merck Merck · Pharma · PA

Merck is seeking a Senior Study Manager to provide operational support for epidemiology research studies. This role involves managing the full lifecycle of observational and non-interventional studies, including planning, execution, vendor management, data integrity, and publication support, all while ensuring compliance with GPP and SOPs.

What you'd actually do

  1. Operational planning and project management of epidemiology research studies
  2. Execution, and close out of primary data collection, chart review, database, and molecular epidemiology studies in addition to other activities
  3. Manage vendors including qualification efforts, confidentiality agreements, specifications, and contract reviews
  4. Assist with review and finalization of all vendor documents such as the safety management, data management, communication, project management and validation plans
  5. Participate in protocol and interim/final report preparation, shepherd document through the internal review process for approval, and upload to department repository

Skills

Required

  • Five (5)+ years of work experience within clinical/observational research or equivalent experience; or PhD with 3+ years relevant career experience
  • Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders
  • Knowledge of epidemiology and/or outcomes research
  • Strong project management and prioritization skills
  • Highly motivated, able to work independently and collaboratively

What the JD emphasized

  • Good Pharmacoepidemiology Practice (GPP)
  • Standard Operating Procedures (SOPs)
  • compliance requirements