Senior Clinical Project Manager
New
B
BDMedical Devices
GermanyFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- Minimum of 4 years project management experience and minimum 6 years of clinical study experience.
- Required Skills
- Project ManagementGCPBudgeting
Requirements
- Bachelor's degree in life sciences, clinical, or relevant technical areas.
- Minimum 6 years of clinical study experience, preferably in medical devices, IVD, pharmaceutical, or biotechnology.
- Minimum 4 years of project management experience.
- Proven ability to oversee clinical teams in multicenter, global complex studies.
- Proficiency in Good Clinical Practice (GCP), FDA, and ISO regulations.
- Knowledge of MDR/IVDR and current industry practices.
- Familiarity with CLSI guidelines and international clinical research standards.
- Project management expertise, with PMP certification preferred.
- Demonstrated ability to work independently in a virtual, international environment.
- Capability to travel approximately 20% worldwide.
Responsibilities
- Serve as project lead for complex clinical trials from protocol development through study conduct and close-out.
- Ensure study execution within overall timelines and deliverables.
- Identify, escalate, and manage risks and issues to ensure cost-effective, timely project delivery.
- Collaborate with global project management, Data Management, Statistics, and Medical Affairs.
- Oversee and train study-specific local clinical resources, including contractors and CROs.
- Develop and oversee clinical study budgets, including invoice review and monthly accruals.
- Manage relationships with clinical sites, PIs, and study-related vendors.
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