Clinical Operations Leader, Specimen Management

BD; Illinois; On-site; USD 138,000 - 220,000; Full time

Benefits offered by this job

Annual Bonus

Medical coverage

Dental coverage

Vision coverage

Paid time off

Job summary

BD's Franklin Lakes location is seeking a Manager, Clinical Operations (Specimen Management) to lead a team of Clinical Project Managers across global studies, ensuring study conduct aligns with ICH-GCP and regulatory standards.

You will oversee TMF activities, enable efficient study execution, manage budgets, and collaborate with sites, CROs, and internal teams while traveling up to 30% domestically and internationally.

Qualifications

• Bachelor's degree and 7+ years in clinical studies with cross-functional leadership
• Strong knowledge of clinical trial concepts, regulatory requirements, and ICH-GCP
• Hands-on TMF management experience ensuring inspection-readiness

Responsibilities

• Lead and develop a team of Clinical Project Managers to meet timelines and quality standards
• Oversee study start-up documents, monitoring plans, and study deliverables for quality and compliance
• Monitor KPIs, risks, and budgets; collaborate with sites, CROs, and internal stakeholders

Skills

Team leadership

Project management

Cross-functional collaboration

Communication skills

Budget management

Regulatory compliance

ICH-GCP knowledge

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Tools

TMF familiarity

Excel advanced

MS Office/CRM tools

Job description

BD's Franklin Lakes location is seeking a Manager, Clinical Operations (Specimen Management) to lead a team of Clinical Project Managers across global studies, ensuring study conduct aligns with ICH-GCP and regulatory standards.

You will oversee TMF activities, enable efficient study execution, manage budgets, and collaborate with sites, CROs, and internal teams while traveling up to 30% domestically and internationally.