Clinical Operations Consultant

Leapfrog Bio; United States; Hybrid; USD 100,000 - 140,000; Part time

Job summary

A biopharmaceutical company is seeking a Clinical Operations Consultant to lead the execution of a Phase 1b/2a precision oncology trial on a part-time basis. The ideal candidate will have over 10 years in clinical operations within oncology, with strong skills in GCP compliance and risk-based monitoring. Responsibilities include providing leadership across trial operations, monitoring patient enrollment, and collaborating with regulatory and clinical teams to ensure successful trial execution.

Qualifications

• Over 10 years of experience in clinical operations with a focus on oncology.
• Ability to travel to clinical sites and foster partnerships with CROs.
• Solid experience in managing clinical trial budgets.

Responsibilities

• Lead clinical operations for oncology trials, ensuring compliance and efficiency.
• Monitor patient enrollment and implement strategies to enhance participation.
• Collaborate with cross-functional teams for aligned trial execution.

Skills

Clinical operations leadership

Risk-based monitoring

Strong communication

GCP compliance

Oncology trial experience

Tools

CTMS

EDC

eTMF

IRT

Job description

We are seeking a seasoned Clinical Operations Consultant to lead the execution of a Phase 1b/2a precision oncology clinical trial in solid tumors on a part-time / fractional basis. This role is ideal for a senior professional (Director or above) with deep operational, GCP, and vendor oversight experience who thrives in fast-paced, resource-constrained environments.

Responsibilities

• Provide senior-level clinical operations leadership across oncology trials, supporting protocol development, feasibility assessments, and operational strategy.
• Serve as a strategic advisor to the CEO by proactively identifying potential risks to the clinical trial and implementing effective mitigation strategies to ensure trial continuity and success.
• Travel to U.S. clinical sites for qualification, initiation, monitoring, QC, and close-out visits.
• Partner with the leadership team in CRO and specialty vendor vetting and selection, including contributions to the RFP process, proposal reviews, and operational due diligence.
• Support negotiation of scope, timelines, and deliverables with selected vendors.
• Play a key role, in collaboration with the acting CMO and Clinical Research Organization, on the development of a patient enrollment strategy.
• Monitor and report patient enrollment statistics to the leadership team. Proactively drive patient enrollment by identifying opportunities to increase enrollment and supporting site-level troubleshooting.
• Improve the quality, efficiency, and safety oversight of the study through the development and implementation of risk-based monitoring.
• Proactively monitor site compliance, resolve deviations, and implement corrective action plans to reduce protocol violations.
• Manage clinical data quality, ensuring timely and accurate data entry, query resolution, and alignment with EDC systems.
• Ensure GCP compliance and inspection readiness through documentation review, site training, and audit support.
• Report and monitor clinical trial budgets, forecast expenses, and track change orders in collaboration with finance.
• Partner cross-functionally with regulatory, biometrics, clinical science, and medical teams to ensure aligned trial execution.
• Use clinical systems (e.g., CTMS, EDC, eTMF, IRT/IWRS) to monitor site performance, document trial milestones, and track compliance.
• Support operational workflows involving next-generation sequencing (NGS) as a key patient selection criterion, including logistics, turnaround time tracking, and data reconciliation.
• Interface with central NGS screening laboratories to coordinate timely reporting of biomarker data for eligibility confirmation.
• Outline processes for integrating central labs (for biomarker testing) into the patient screening workflow, ensuring timely eligibility confirmation.

Required Qualifications

• 10+ years of experience in clinical operations, with demonstrated leadership in oncology trials.
• Previous experience with implementing risk-based monitoring programs.
• Ability to travel to clinical sites and experience building positive partnerships with CROs and clinical site personnel.
• Solid tumor experience is required; precision oncology and biomarker-driven trial experience strongly preferred.
• Proven success in reducing protocol violations and improving site enrollment performance.
• Strong track record (defined as on time, on budget and with minimal protocol deviations) with Phase 1b/2a and late-phase studies.
• Deep knowledge of Good Clinical Practice (GCP), ICH guidelines, and U.S. regulatory requirements.
• Experience conducting site qualification/initiation/close-out visits and active site monitoring and site remediation training if necessary.
• Demonstrated experience participating in CRO/vendor selection and RFP processes, including proposal evaluation and operational input.
• Proficient in clinical systems such as CTMS, EDC, eTMF, and IRT.
• Experience with budget development, site payments, and financial oversight.
• Willingness to travel domestically to clinical sites as needed.
• Experience coordinating with central labs to confirm biomarker eligibility for patient inclusion.
• Proven ability to successfully and effectively interface with world-class level clinical investigators and their study coordinators while representing the sponsor at the highest levels of ethical and professional conduct.

Preferred Qualifications

• Background in precision oncology, companion diagnostics, or targeted therapy trials. Deep operational experience with next-generation sequencing (NGS) in clinical trials, particularly in its use as a diagnostic and patient selection tool.
• Prior experience in FDA or EMA inspection preparation.
• Clinical development experience within small biotech or emerging oncology companies.

Seniority level

• Director

Employment type

• Part-time

Job function

• Research, Analyst, and Information Technology

Industries

• Biotechnology Research and Pharmaceutical Manufacturing