Clinical Operations Regional Lead

BioTalent; United States; On-site; USD 123,984 - 158,424; Full time

Job summary

A leading healthcare company is looking for a motivated Regional Lead of Clinical Operations to oversee clinical trials, ensuring compliance with regulations and optimal performance. The candidate should have extensive experience in clinical research, particularly in oncology, and a strong background in managing vendors. This mid-senior level contract role offers competitive pay and the opportunity to make a significant impact in cancer therapy development.

Qualifications

• Minimum of 6 years of experience in clinical research and drug development.
• Experience in early-phase oncology trial management.
• Strong understanding of FDA and ICH/GCP regulations.

Responsibilities

• Oversee operational oversight and execution of clinical trials.
• Manage CROs and clinical vendors to meet project objectives.
• Support audits and inspections as needed.

Skills

Clinical research

Vendor management

Regulatory knowledge

Interpersonal skills

Analytical skills

Problem-solving

Education

Bachelor’s degree in life sciences

Job description

Base pay range

$90.00/hr - $115.00/hr

A growing precision oncology company is seeking a talented, experienced, and highly motivated Regional Lead of Clinical Operations with a passion for developing innovative cancer therapies. This role is responsible for regional operational oversight and execution of one or more clinical trials from start-up through closeout, specifically for early-stage clinical programs.

As a Regional Lead, you will work closely with cross-functional teams—including Medical Monitoring, Clinical Science, Data Management, Regulatory, Biostatistics, Pharmacology, and Translational Science—to ensure the timely and high-quality delivery of clinical trial milestones. You will apply both technical expertise and strategic oversight to drive clinical trial planning and execution.

Key Responsibilities

• Support the Study Lead and Study Execution Team (SET) in initiating and delivering clinical trials on time, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines
• Assist with vendor selection processes including RFP development and bid defense participation
• Manage CROs and clinical vendors to ensure project objectives are met
• Contribute to and review clinical documents such as protocols, ICFs, CRFs, manuals, and study plans
• Serve as subject matter expert on internal initiatives and SOP/process development
• Oversee vendor contracts, manage budgets and accruals, and reconcile invoices
• Support implementation of clinical systems including CTMS, TMF, EDC, and IRT
• Conduct clinical data reviews, generate queries, and oversee data integrity
• Manage site-level activities including monitoring reports, recruitment metrics, and quality oversight in collaboration with CROs
• Participate in study start-up activities such as site selection and protocol deviation reviews
• Track study metrics, identify challenges, and drive resolution strategies
• Proactively manage study risks and recommend mitigation solutions
• Build strong working relationships with internal teams, vendors, CROs, and site staff
• Train investigators, site staff, and team members on study conduct and protocols
• Ensure TMF is inspection-ready and conduct regular QC reviews
• Support audits and inspections as needed
• Travel domestically and internationally (approximately 20%)
• Perform additional responsibilities as assigned

Qualifications

• Bachelor’s degree in life sciences or a related discipline
• Minimum of 6 years of experience in clinical research and drug development
• Advanced knowledge of domestic and global clinical study management
• Proven experience in vendor management within oncology clinical trials
• Strong understanding and application of FDA and ICH/GCP regulations and guidelines
• Experience in early-phase oncology trial management, including precision medicine studies
• Self-motivated with a drive for continuous improvement and innovation
• Collaborative team player with strong interpersonal and relationship-building skills
• Detail-oriented and creative thinker with a focus on process optimization
• Excellent organizational, analytical, and communication skills (both verbal and written)
• Ability to triage issues, prioritize effectively, and implement solutions
• Willingness and ability to travel up to 20%
• Ability to work in Pacific Time

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Management and Science

Industries

Pharmaceutical Manufacturing and Research Services