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Project Manager_Scientific I (Assistant)
Ref No.: 17-13736
Location: RAHWAY, New Jersey
Under general supervision of the Associate Director of Study Management- Strategy & Operations within Center for Observational and Real-World Evidence (CORE), the project manager provides support in the planning and execution of observational research studies conducted within CORE, part of Client Research Laboratories. In addition, the project manager may participate in process improvement initiatives. • 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. Supports the Lead CORE Scientist in overall operational activities for study conduct • Main responsibilities include study level project management support such as: o Review request for information/proposal, draft statements of work, lead contract/change order activities through execution and manage budgets/invoices for outsourced projects o Coordinate confidentiality and consultant agreements o Coordinate internal/external meeting management and draft/review agenda/minutes o Track timelines/deliverables and follow up on action items o Liaise with vendor and cross functional teams to communicate project status and/or needs o Participate in protocol and interim/final report preparation, shepherd documents through internal review process for approval and submit to internal repository o Review all vendor documents such as monitoring, project management, safety management, data management and validation plans o 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 describe 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 • Participate in CORE wide process improvement initiatives

Quals--
Education: • Bachelor's degree required • Master's degree a plus in epidemiology (or closely related discipline, such as biostatistics, biometry, public health or biological sciences) Required Experience and Skills: • Exposure to clinical/observational research (1-3 years related job experience, or equivalent experience) • Must have strong communication and organizational skills • Basic knowledge of epidemiologic or outcomes research • Strong project management skills