Project Manager Scientific I

Job Title

Qualifications:

Education:

Bachelor's degree is required. Master's degree is desirable/preferred.

Required Experience and Skills:

• A background in public health, epidemiologic, clinical and/or outcomes research.
• 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

Preferred Experience and Skills:

• 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

Responsibilities:

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 Client Research Laboratories (MRL).

Main responsibilities include general project management support such as:

• 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

Additional Responsibilities Include:

• 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

Comments/Special Instructions:

Position can be located in Philadelphia, Upper Gwynedd or Rahway.

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.