Clinical Operations Leader — Specimen Management

BD; Franklin Lakes (NJ); On-site; USD 138,000 - 220,000; Full time

Benefits offered by this job

Annual Bonus

Medical coverage

Health Savings Accounts

Flexible Spending Accounts

Dental coverage

Vision coverage

Life and AD&D insurance

Job summary

BD is seeking a Manager of Clinical Operations (Specimen Management) to lead a team of Clinical Project Managers through complex, global studies in compliance with GCP and regulatory standards. You will mentor staff, manage study budgets, and coordinate with CROs and internal stakeholders.

The role requires 7+ years in clinical study management, TMF oversight, and strong leadership with a strategic, process-improvement mindset. Located in USA NJ (Franklin Lakes) with up to 30% travel.

Qualifications

• Bachelor's degree required in life sciences, clinical or related technical areas.
• 7+ years of clinical study experience with leadership of cross-functional teams.
• Hands-on TMF management ensuring inspection-readiness and regulatory compliance.
• Strong budgeting, forecasting and strategic program management skills.

Responsibilities

• Lead and develop a team of Clinical Project Managers to meet timelines, quality, and deliverables.
• Set objectives and performance expectations for the Clinical Project Managers and monitor progress.
• Oversee study documents (protocols, ICFs, CRFs, monitoring plans) for quality and timely execution.
• Optimize resource allocation and support continuous improvement in study execution.
• Travel up to 30% domestically and internationally.

Skills

Team leadership

Cross-functional collaboration

Project management

GxP/ICH-GCP knowledge

Mentoring/people development

Education

Bachelor's degree

Job description

BD is seeking a Manager of Clinical Operations (Specimen Management) to lead a team of Clinical Project Managers through complex, global studies in compliance with GCP and regulatory standards. You will mentor staff, manage study budgets, and coordinate with CROs and internal stakeholders.

The role requires 7+ years in clinical study management, TMF oversight, and strong leadership with a strategic, process-improvement mindset. Located in USA NJ (Franklin Lakes) with up to 30% travel.