Senior Clinical Project Manager: Global Trial Lead

BD; United States; Remote; USD 101,000 - 146,000; Full time

Job summary

BD in Germany seeks a Senior Clinical Project Manager to lead multiple, high-complexity clinical trials from protocol through close-out in compliance with GCP, FDA, ISO, MDR/IVDR standards. You will mentor other PMs and CRAs and coordinate with CROs and internal BD teams across borders.

The role requires a life sciences degree, 4+ years PM experience, and 6+ years of clinical study experience, plus travel ~20%.

Qualifications

• Minimum 4 years of project management experience.
• Minimum 6 years of clinical study experience, in medical device, IVD, pharmaceutical, biotechnology, CRO.
• Familiarity with CLSI guidelines and related standards.
• PMP certification is a preferred goal for Clinical Project Managers.
• Proficient understanding of GCP, FDA and ISO regulations, MDR/IVDR and related industry practices.
• Ability to travel approximately 20% worldwide.

Responsibilities

• Lead and manage complex clinical trials from protocol development through conduct and closeout.
• Ensure execution within study timelines and deliverables; manage risks and issues.
• Collaborate with global project management, DM and Statistics, and Medical Affairs.
• Oversee and train study-specific local resources (contractor CRAs, CROs).
• Develop and oversee clinical study budgets including invoices and accruals.
• Define, track and report on project management schedule attributes.

Skills

Project management

Team leadership

Communication

Negotiation

Independent work

Travel readiness

Education

Bachelor's degree in life sciences or related field

Job description

BD in Germany seeks a Senior Clinical Project Manager to lead multiple, high-complexity clinical trials from protocol through close-out in compliance with GCP, FDA, ISO, MDR/IVDR standards. You will mentor other PMs and CRAs and coordinate with CROs and internal BD teams across borders.

The role requires a life sciences degree, 4+ years PM experience, and 6+ years of clinical study experience, plus travel ~20%.