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Project Manager

Company: N/A

Location: West Point, PA

Pay: N/A

Contact Information

Name: Nites
Phone: 6506845952
Fax: n/a
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Job Description

Title: Project Manager

Duration: 12 months

Location: west point, PA

Job Description & Requirements


Bachelor's degree required

Master's degree a plus in public health, pharmaceutical sciences, quality assurance (or closely related disciplines)

Required Experience and Skills:

Exposure to clinical or observational research (1-3 years related professional experience)

Basic knowledge of epidemiologic or outcomes research

Strong project management skills

Experience with Office 365 tools; knowledge of SharePoint configuration is highly desired; experience with developing highly effective presentation slide decks is also a plus

Knowledge of quality, quality management systems (QMS), and/or compliance functions related to clinical or observational research

Experience with the coordination/tracking of and participation in internal/external audits/inspections

Experience with the development and maintenance of Standard Operating Procedures (SOPs)

Must have strong communication (oral/written), organizational, interpersonal and time management skills

Must be proactive and able to work independently

Must be flexible and able to manage multiple deadlines simultaneously

Working knowledge and understanding of GXP regulations \

Under general supervision of the Associate Director - Strategy & Operations within Center for Observational and Real-World Evidence (CORE), the project manager provides support for the maintenance of CORE’s Quality Management System (QMS) and quality related activities, such as Quality Control, Quality and Compliance Council, Audit Taskforce, CORE Standards, and Risk Management activities in alignment with the rest client Research Laboratories (MRL).

•Support includes the ongoing improvement and coordination of the quality and compliance activities (i.e. QMS) for the observational research studies conducted within CORE, part of MRL.

•Main responsibilities include project management support such as:

o Coordinate internal/external meeting management and draft/review agenda/minutes for quality initiatives

o Track timelines/deliverables and follow up on action items/CAPAs for audits, inspections, significant quality issues and quality control assessments; ensure documents are in conformance to appropriate regulatory requirements when applicable

o Assist with the development and maintenance of IT systems and other solutions (e.g. SharePoint) to support the quality activities which includes communicating requirements to cross-functional partners or stakeholders (e.g. IT)

o Assist with the development of project specific guidance, training documents

o Participate in and contribute to project teleconferences

o Liaise with cross functional teams to communicate project status and/or needs; follow up in a timely manner to ensure all timelines are met quickly (ex. Audit responses)

o Participate in presentation preparation and the shepherding of documents through review process

o Act as a champion for quality and compliance within CORE

o Troubleshoot issues as they arise and work to bring to timely resolution

o Present project updates to relevant stakeholders

· Participate in continuous improvement efforts to ensure CORE studies/projects operate according to requirements

· Support current SMEs and track decisions/lessons learned to help evolve COREs QMS strategy

Job Requirements