Clinical Operations Regional Lead

We are seeking an experienced clinical operations professional to lead and support regional trial execution across early-phase oncology studies. This role partners closely with cross-functional colleagues in clinical development, data management, regulatory affairs, biostatistics, translational science, pharmacology, and external collaborators to ensure the successful planning and delivery of clinical programs.

Overview

This is a 1099 contract position. The candidate MUST BE BASED IN PST/WEST COAST and MUST HAVE WORKED AS A 1099 CONSULTANT. The compensation is $100-$120/hr.

• Partner with the Study Lead and Study Execution Team (SET) to initiate and oversee clinical trials, ensuring projects are delivered on schedule, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
• Lead or contribute to the RFP process, vendor selection, and bid defense meetings to identify CROs and clinical vendors aligned with strategic needs.
• Manage relationships with CROs and vendors to ensure milestones and corporate objectives are achieved.
• Oversee site performance, including monitoring report review, recruitment status, and quality metrics, resolving issues in collaboration with internal functions and CRO partners.
• Draft, review, and contribute to core clinical documents such as protocols, ICFs, CRFs, study manuals, and study plans.
• Oversee fiscal aspects of clinical programs: manage vendor contracts, support financial forecasting, reconcile accruals, and ensure accuracy of work orders and change orders.
• Implement and manage clinical trial systems (CTMS, TMF, EDC, IRT) and oversee proper data review, including query generation and issue resolution.
• Support study start-up, site selection, patient recruitment, TMF review, and protocol deviation management.
• Review and track study metrics; proactively identify risks and implement mitigation strategies.
• Act as SME on departmental initiatives, contributing to SOP and process development.
• Maintain inspection readiness, support audits/inspections, and ensure TMF quality throughout the study lifecycle.
• Train investigators, site staff, vendors, and internal team members on trial processes.
• Build and maintain strong relationships with cross-functional teams, CROs, vendors, and clinical site personnel.
• Travel domestically and internationally as needed (up to ~10%).

• Bachelor’s degree in life sciences or related field with 6+ years’ experience in clinical operations/drug development.
• Demonstrated knowledge of U.S. and global clinical study execution and vendor oversight.
• Experience in oncology clinical trials required; early-phase and precision medicine trial experience strongly preferred.
• Strong understanding of FDA regulations, ICH/GCP, and global trial conduct requirements.
• Excellent organizational, analytical, and problem-solving skills; ability to anticipate and address study challenges.
• Proven ability to manage multiple vendors and cross-functional stakeholders.
• Motivated, collaborative, and adaptable team player with excellent communication skills.
• Detail-oriented, process-focused, and open to continuous improvement and innovation.

Base pay range: $100.00/hr - $120.00/hr

Seniority level:
Mid-Senior level

Employment type:
Contract

Job function:
Research, Project Management, and Science

Bio Phase is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive environment for all employees.