Project Manager

PROJECT MANAGER
PHILADELPHIA, PA
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: kevin@alphaconsulting.com

ALPHA'S REQUIREMENT #23-00489
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE