Senior Clinical Operations Lead — Specimen Management

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

Benefits offered by this job

Annual Bonus

Medical coverage

Health Savings Accounts

Dental coverage

Vision coverage

Life and AD&D insurance

PTO and leaves

Job summary

BD is seeking a Manager of Clinical Operations (Specimen Management) to lead a team of Clinical Project Managers through multi-site, high-complexity studies in compliance with ICH-GCP and regulatory standards. You will guide protocol development, TMF oversight, and cross-functional collaboration with internal teams and CROs to ensure timely, quality execution.

The role requires a strong background in clinical study management, budgeting, and risk mitigation, with travel up to 30% domestically

Qualifications

• Bachelor's degree required; life sciences or related field preferred.
• Minimum of 7 years of clinical study experience in pharma, medical device, IVD, biotech or CRO.
• Hands-on TMF management and regulatory compliance (ICH-GCP).
• Strong budgeting, forecasting and financial acumen.
• Proven ability to lead cross-functional clinical teams and manage complex global studies.
• Excellent written and verbal communication; stakeholder management.
• PMP certification and advanced degree are preferred.

Responsibilities

• Lead and develop a team of Clinical Project Managers to meet timelines, quality standards and deliverables.
• Provide oversight for study documents (protocols, ICFs, monitoring plans, etc.) ensuring quality and compliance.
• Oversee resource allocation and budget forecasting for multiple studies.
• Mentor and develop junior staff; drive professional growth.
• Lead continuous improvement initiatives for study execution efficiency and compliance.
• Support audits, CAPA development and root cause analyses.

Skills

Clinical leadership

Project management

Cross-functional collaboration

Regulatory knowledge

Quality assurance

Process improvement

Education

Bachelor's degree

Tools

Excel

Job description

BD is seeking a Manager of Clinical Operations (Specimen Management) to lead a team of Clinical Project Managers through multi-site, high-complexity studies in compliance with ICH-GCP and regulatory standards. You will guide protocol development, TMF oversight, and cross-functional collaboration with internal teams and CROs to ensure timely, quality execution.

The role requires a strong background in clinical study management, budgeting, and risk mitigation, with travel up to 30% domestically