Project Manager
Alpha Consulting | Philadelphia, PA, 19107, USSalary Range:$83,000 – $116,000 Salary range estimated by Zippia
Posted 14 days ago
Description
PROJECT MANAGER
PHILADELPHIA, PA
Project Description:
Required Skills:
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
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