Senior Clinical Operations Manager, Specimen Management

BD; United States; Remote; USD 138,000 - 220,000; Full time

Benefits offered by this job

Annual Bonus

Health and Well-being Benefits

BD 401(k) Plan

Job summary

BD in the USA (Franklin Lakes, NJ) seeks a Manager, Clinical Operations (Specimen Management) to lead a team responsible for multicenter clinical studies from protocol through closeout in compliance with ICH-GCP. The role involves strategic direction, cross-functional collaboration, and oversight of TMF activities.

The ideal candidate has 7+ years in clinical study management, strong TMF expertise, and proven ability to manage budgets and timelines.

Qualifications

• 7+ years in clinical study experience with cross-functional leadership
• Hands-on TMF management ensuring inspection readiness
• Experience with global multicenter studies from initiation to closeout
• Strong knowledge of international clinical research guidelines and regulatory requirements

Responsibilities

• Lead and develop a team of Clinical Project Managers to meet timelines, quality standards and deliverables
• Provide oversight of start-up documents to ensure quality and timely execution
• Oversee study resource allocation and budget forecasting
• Mentor Clinical Project Managers and drive professional growth
• Collaborate with sites, PI, CROs and internal stakeholders on study direction and execution
• Monitor key performance indicators and risk mitigation across studies

Skills

Team leadership

Clinical operations

TMF management

Budget forecasting

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in life sciences or related field

Tools

Microsoft Office Suite

Job description

BD in the USA (Franklin Lakes, NJ) seeks a Manager, Clinical Operations (Specimen Management) to lead a team responsible for multicenter clinical studies from protocol through closeout in compliance with ICH-GCP. The role involves strategic direction, cross-functional collaboration, and oversight of TMF activities.

The ideal candidate has 7+ years in clinical study management, strong TMF expertise, and proven ability to manage budgets and timelines.