CORE Study Manager- Epidemiology
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
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 Merck 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 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 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 initiative
- Master's degree in epidemiology (or closely related discipline, such as biostatistics, public health, health administration or biological sciences)
- 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.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Resch Science Proj/Prog Mgmnt
Employee Status: Regular
Travel: Yes, 5 % of the Time
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Company Trade Name: Merck