Project Manager leading complex client implementations at Caseware, an established Fintech company. Responsible for delivery excellence, stakeholder governance, and cross - functional collaboration.
DF
Hybrid Senior Manager, Clinical Affairs Project Management
Posted 3 months ago
About the role
- Senior Manager leading clinical project management initiatives for global markets in the medical device industry. Ensuring compliance and operational excellence throughout clinical study phases.
Responsibilities
- Lead and oversee clinical project management activities for multiple studies, ensuring adherence to timelines, budgets, and quality standards.
- Manage and mentor Clinical Project Managers and support staff, fostering a culture of accountability and continuous improvement.
- Champion process improvement initiatives to optimize workflows, establish best practices, and ensure consistent, efficient project management across all clinical studies.
- Develop and implement project plans, risk mitigation strategies, and contingency plans.
- Serve as the primary liaison between Clinical Affairs and cross-functional teams (Medical Affairs, R&D, Regulatory, Quality, Legal, and Operations).
- Oversee vendor selection, contract negotiations, and performance management for CROs and other external partners.
- Ensure compliance with applicable regulatory requirements, including GCP, ISO 14155, and FDA guidelines.
- Monitor study progress, resolve complex issues, and escalate as needed to senior leadership.
- Contribute to protocol development, IDE submissions, and interactions with regulatory authorities.
- Prepare and present project status reports and key performance metrics to stakeholders.
Requirements
- Bachelor’s degree in Life Sciences, Health Sciences, or related field (advanced degree preferred)
- Minimum 8+ years of experience in clinical research or project management within the medical device or pharmaceutical industry
- Proven experience managing global clinical trials and cross-functional teams
- Strong knowledge of regulatory requirements and clinical trial processes
- Diabetes experience highly desirable.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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