Clinical Operations Lead — Specimen Management

BD; Town of Texas (WI); 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

Job summary

BD is seeking a Manager, Clinical Operations (Specimen Management) to lead a team of Clinical Project Managers responsible for multiple complex studies, from protocol development through study closeout, ensuring compliance with ICH-GCP and regulatory standards. You will partner with cross-functional teams, manage budgets and timelines, mentor staff, and drive process improvements across study programs.

Domestic and international travel up to 30% is required; on-site collaboration is emphasized

Qualifications

• Minimum of 7 years of clinical study experience leading cross-functional teams.
• Strong knowledge of ICH-GCP and regulatory standards.
• Experience with TMF management and study start-up documents.

Responsibilities

• Lead and develop a team of Clinical Project Managers, ensuring study teams meet timelines, quality, and deliverables.
• Establish objectives and development plans for Clinical Project Managers and monitor performance.
• Provide oversight for essential study documents (protocols, ICFs, monitoring plans, CRFs).
• Oversee and optimize allocation of study management resources.
• Coach and mentor team members for professional growth.
• Lead continuous improvement initiatives to enhance study execution quality and compliance.
• Support audits and CAPA activities for compliance and improvement.
• Foster collaboration with sites, PI's, CROs, and vendors.
• Manage integrated project plans and cross-functional discussions.
• Monitor KPIs, milestones, and risk management.

Skills

Leadership

Cross-functional collaboration

Strategic thinking

Mentoring

Project management

Budget forecasting

Communication skills

Problem-solving

Education

Bachelor's degree in life sciences, clinical or related field

Tools

Microsoft Office Suite

Excel (Pivot Tables, VLOOKUP)

Job description

BD is seeking a Manager, Clinical Operations (Specimen Management) to lead a team of Clinical Project Managers responsible for multiple complex studies, from protocol development through study closeout, ensuring compliance with ICH-GCP and regulatory standards. You will partner with cross-functional teams, manage budgets and timelines, mentor staff, and drive process improvements across study programs.

Domestic and international travel up to 30% is required; on-site collaboration is emphasized