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Public Health Project Manager: Clinical and Observational Research
Ref No.: 18-37447
Location: Upper Gwynedd, Pennsylvania
Position Type:Contract
Job Category:Biotech/Pharmaceutical
Benefits:401K, Dental Insurance, Medical Insurance
*23 month contract position with additional opportunity based upon performance and continued business need*

Education: • Bachelor's degree required
• Master's degree a plus in public health (or closely related discipline, such as biostatistics, biometry, epidemiology 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
• Strong project management skills
• Ability to be flexible and manage multiple projects and deadlines simultaneously
• Ability to work independently
• Basic knowledge of epidemiology or outcomes research 

Under general supervision of the Associate Director of Study Management - Strategy & Operations within the Center for Observational and Real-World Evidence (CORE), the project manager primarily provides operational support to multiple Scientific CORE Leads, which may be across Therapeutic Areas. Support includes the planning and execution of observational research studies conducted within CORE, part of Merck Research Laboratories. In addition, the project manager may participate in process improvement initiatives.

Key Functions: • Supports the Lead CORE Scientist in overall operational activities for in-house and outsourced studies and projects. Coordinates all aspects of observational/non-interventional research studies which include the operational planning and implementation of primary and secondary data collection studies, including chart reviews, survey collection, and database studies. Coordinates all operational aspects of and may contribute to non-study deliverables such as Dossiers, Economic Models, Risk Management Plans or other regulatory documents, and literature reviews.
• Main responsibilities include study and project level support such as:
o Coordinate internal/external meeting management and draft/review agenda/minutes
o Track timelines/deliverables and follow up on action items
o Drive project teleconferences o Review request for information/proposals, draft statements of work, lead contract/change order activities through execution and manage budgets/invoices for outsourced projects
o Coordinate execution of confidentiality and consultant agreements
o Liaise with vendors, cross functional teams, and subsidiaries to communicate project requirements, status, and/or project specific needs
o Participate in protocol and interim/final report preparation, shepherd documents through internal document review process for approval and submit to internal repository
o Coordinate the development of abstracts, posters, and manuscripts by following all internal processes 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
o Conduct literature searches and reviews and produce comprehensive summary of results
• 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 be able to 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
• May participate in CORE wide process improvement initiatives
• May present projects or scientific findings to Study Management Group or CORE Teams 

Pay Rate: $45.00 per hour
Drug and background screenings required

On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.