Pharmacoepidemiology Study Manager, MERCK

Job Description

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.

The goal of CORE (Center for Observational and Real-World Evidence) is to generate strategic value evidence and collaborate on the development of market access strategies for our companies products throughout the world. The Study Management organization sits within the Strategy & Operations group in CORE. This position, under the supervision of a Director or Associate Director, will support study management activities such as study planning, study execution, and summarization of results from observational research studies.  There may also be the opportunity to participate in process improvement initiatives and/or mentoring of new staff.

CORE Study Management Role

• Coordinates all aspects of observational or non-interventional research studies which include the planning and implementation of primary data collection, chart review/survey and database studies. Support the Lead CORE Scientist in overall operational support for study conduct.
• Main responsibilities include study level project management support such as:
  • Review request for information/proposal, draft statements of work, lead contract/change order activities through execution and manage budgets/invoices for outsourced projects
  • Coordinate confidentiality and consultant agreements
  • Coordinate internal/external meeting management and draft/review agenda/minutes
  • Track timelines/deliverables and follow up on action items
  • Assist in managing study level budget which includes follow up of invoices, tracking spend, managing Systems Applications and Products (SAP) (when applicable) and communicating with stakeholders such as Finance and the Budget Management organization
  • Liaise with vendor and cross-functional teams to communicate project status and/or needs
  • Participate in protocol and interim/final report preparation, shepherd document through the internal review process for approval and submit to internal repository
  • Review all vendor documents such as monitoring, project management, safety management, data management, and validation plans
  • Participate in quality control and integrity of study data and reports for publications
• Provide operational support to ensure studies follow all CORE processes for informed consent, compliance, site contract, and budget review/approval, protocol document review, study registration (when applicable),  IT assessment and/or privacy, vendor qualification, adverse event reconciliation, and publication submission.
• Must understand and describes procedures for observational studies to internal and external stakeholders such as outside investigators/vendors and key opinion leaders.Troubleshoots sourcing/study issues as they arise and work to bring to timely resolution
• May participate in mentoring contract staff. 
• Participate in process improvement initiatives

Educational Qualifications:

• Required: Bachelor’s degree
• Preferred: Master’s degree in epidemiology or closely related discipline, such as biostatistics, public health, health administration or biological sciences

Required Experience and Skills:

• Two (2) or more years of work experience within clinical/observational research or equivalent experience. 
• Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders. 
• Basic knowledge of epidemiologic or outcomes research
• Strong project management skills
• Highly motivated, able to work independently, raising issues with recommendations for solutions.

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