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Project Manager_Scientific I (Assistant)
Ref No.: 18-13890
Location: UPPER GWYNEDD, Pennsylvania
Client:                                Pharma Client
Job type:                           Contract
Duration:                           22+ Months
Location:                           Rahway, NJ- Upper Gwynedd, PA  
Title:                                   Project Manager Scientific I
ID:                                       24270
 
Job description:
  •  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 the client's 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:
  • Coordinate internal/external meeting management and draft/review agenda/minutes.
  • Track timelines/deliverables and follow up on action items.
  • 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
  • Coordinate execution of confidentiality and consultant agreements
  • Liaise with vendors, cross functional teams, and subsidiaries to communicate project requirements, status, and/or project specific needs
  • Participate in protocol and interim/final report preparation, shepherd documents through internal document review process for approval and submit to internal repository
  • Coordinate the development of abstracts, posters, and manuscripts by following all internal processes
  • 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
  • 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 
 
       Qualifications:
       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