The Role
Serve as project management process owner for Periodic Safety Update Reports (PSURs): optimize processes, deploy consistent PM methodologies, manage project tools (Microsoft Project, LeanKit), support audits/inspections, retrieve and route documents within medical device quality systems, track metrics (PSURs, CERs, safety surveillance), lead/project-manage staff, and partner cross-functionally with medical, R&D, regulatory, and quality teams.
Summary Generated by Built In
Responsibilities:
- The Project Coordinator, Shared Services acts as the project management process owner. This role focuses on process optimization and the deployment and utilization of consistent project management methodologies in support of the execution of Periodic Safety Update Reports.
- Knowledge and access to applicable Medical Device Quality Systems to support the teams in document retrieval and routing of documents for approval.
- Provide support during audits and inspections pertaining to PSUR processes and reports.
- The Project Coordinator, Shared Services acts as the project management process owner. This role focuses on process optimization and the deployment and utilization of consistent project management methodologies in support of the execution of Periodic Safety Update Reports.
- Knowledge and access to applicable Medical Device Quality Systems to support the teams in document retrieval and routing of documents for approval
- Provide support during audits and inspections pertaining to PSUR processes and reports
- Maintain and execute project management tools, such as, Microsoft projects plans, Lean Kit boards, and monitors smooth execution of project milestones and task levels.
- Provides project management and leadership to staff
- Actively partners with cross-functional business partners such as Medical Directors, PSUR, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the PSUR process
- Ensures strategic plans for operating company PSUR timelines are met and practices are being consistently deployed across the global organization
- Maintains and monitors metrics relevant to team activities such as PSURs, CERs, Safety Surveillance activities, Literature Searches, Literatures Reviews, Compliance Activities, providing visibility of issues and enable corrective and preventive action to be taken as needed
- Collaborate and support the Leadership team through the various processes
Skills and Qualifications:
- Bachelor’s degree in science or above and in alignment with project / business team requirements
- Minimum of 0 to 2 years of relevant experience in identified functional domain/ business workstream
Skills Required
- Bachelor's degree in science or related field
- 0 to 2 years of relevant experience
- Knowledge of and access to Medical Device Quality Systems
- Experience maintaining and executing project plans in Microsoft Project
- Experience using LeanKit or similar Kanban/board tools
- Experience supporting audits and inspections related to PSUR processes
- Project management and team leadership experience
- Ability to collaborate with Medical Directors, Post Market Surveillance, R&D, and Regulatory Affairs
- Ability to maintain and monitor metrics for PSURs, CERs, literature reviews, and compliance activities
ClinChoice Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ClinChoice and has not been reviewed or approved by ClinChoice.
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Flexible Benefits — Flexible arrangements, including telecommuting and flextime with no core hours in some regions, are highlighted for many roles. Feedback suggests flexibility is commonly available but depends on role and location.
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Leave & Time Off Breadth — Vacation, personal, and sick days are part of the core package, with some markets granting paid leave from the date of hire. Feedback suggests time off is standard-to-decent across locations, though specifics vary.
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Healthcare Strength — Health coverage is positioned as a core benefit, with some accounts describing overall benefits as full or good. In the U.S., healthcare sits within a conventional CRO package alongside medical, dental, and vision.
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The Company
What We Do
ClinChoice is a global full-service Contract Research Organization (CRO) specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies, aiming to accelerate the development and commercialization of innovative drugs and devices.
