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Project Management Specialist
2 weeks ago
- Manage interdisciplinary clinical research studies as a project manager, ensuring compliance with GCP, SOPs, and regulatory requirements.
- Act as the primary liaison between the Company and Customer to ensure timely study launch, conduct, and closeout according to contractual agreements.
- Lead the project team to ensure quality, timelines, and budget management.
- Accountable for financial performance and coordinating activities and deliverables of all study conduct partners.
- Proactively identify and manage issues to ensure studies are conducted in compliance with regulations.
- Accountable for all project deliverables.
- Responsible for the quality and completeness of the Trial Master File for assigned projects.
- Accountable for maintaining study information on various databases and systems.
- Responsible for inspection readiness for all aspects of study conduct.
- Oversight for developing and implementing project plans.
- Plan, coordinate, and present at internal and external meetings.
- Prepare project management reports for clients and management.
- Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals.