Project Manager

Project Manager

Alpha Consulting | Philadelphia, PA, 19107, US
Salary Range:$83,000 – $116,000 Salary range estimated by Zippia

Posted 14 days ago

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Project Description:
  • This role is within The Center for Observational and Real-World Evidence (CORE), Strategy and Operations, Quality Management Team.
  • The project manager provides support for the development and maintenance of Non-Interventional (NI) Quality Management System (QMS) related processes and initiatives, such as the Quality and Compliance Council, Audits, NI Standards and Risk Management activities.
  • Support includes the planning, execution and ongoing development and improvement of the QMS and Quality and Compliance department initiatives for non-interventional studies (NIS), part of the Client's Research Laboratories (MRL).
  • Track timelines/deliverables and follow up on action items/CAPAs for audits, inspections, and significant quality issues.
  • Conduct monitoring and tracking of non-interventional quality deliverables and develop associated metrics.
  • Develop department-wide quality metrics, analyze trends, and prepare reports utilizing visualization methods.
  • Create and maintain rich interactive visualizations through data interpretation and analysis through various reporting components.
  • Drive efficiencies for the QMS team through automation and reporting.
  • Assist with the development of IT systems and solutions to support the NI QMS.
  • Support the supplier qualification process.
  • Review NIS protocols from a quality perspective.
  • Coordinate internal/external meeting management and draft/review agenda/minutes for QMS workstreams.
  • Assist with the development of project specific guidance, training documents.
  • Participate in and contribute to project teleconferences.
  • Liaise with cross functional teams to communicate project status and/or needs.
  • Participate in presentation preparation, and the shepherding of documents through internal review process for approval.
  • Act as a champion and representation for the NI Quality and Compliance Council.
  • Participate in process improvements to ensure NIS studies/projects operate according to the NI required processes and standards.
  • Must thoroughly understand and describe NI QMS procedures for observational studies and projects to internal stakeholders such as IT developers, NI Scientists and MRL Cross Functional Colleagues.
  • Troubleshoots issues as they arise and work to bring to timely resolution.
  • Participate in NIS wide process improvement initiatives.
  • May present projects to NIS teams.
  • Day to Day:
    • Project management for quality activities.
    • Tracking and coordinating activities in Veeva vault system.
    • Supporting SOP releases.
    • Deal with working through supplier qualification (external suppliers).
    • Maintaining Share point and dashboards.

Required Skills:
  • Bachelor's degree required.
  • A background in public health, epidemiologic, clinical and/or outcomes research.
  • Background in Clinical research quality.
  • Proficient with Microsoft office applications and SharePoint.
  • Ability to objectively drive significant results through data.
  • Strong communication and interpersonal skills.
  • Strong project management skills including strong organizational and time management skills.
  • Ability to be flexible and manage competing deadlines.
  • Ability to successfully work independently and within a team.
  • Self-starter, detail oriented, able to handle multiple projects simultaneously and comfortable working in a fast-paced environment.
  • Experience in data-centric roles.
  • Basic knowledge of epidemiologic or outcomes research.
  • Basic knowledge of a Quality Management System (QMS) and/or Quality and Compliance functions related to clinical/observational research.
  • Experience with the coordination/tracking of and participation in internal/external audits/inspections.
  • Experience with the development and maintenance of research related Standards/SOPs.
  • Public health/clinical research experience
  • Someone familiar with MS office, Sharepoint is nice to have.
  • Build dashboards for data and utilize excel is nice to have.

This 22+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Kevin: