Clinical Trial Manager II

The Senior Local Operations Manager (LOM) in Oncology is a site-focused role responsible for streamlining communication, managing site relationships, ensuring trial compliance, and supporting trial management activities in a home-based setting.

Location: Remote (US)

Responsibilities

• Serve as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution.
• Understand site operational models and own relationships with critical site stakeholders.
• Contribute to site selection through feasibility participation and site qualification visits.
• Ensure local/country team meets recruitment targets with high-quality data within budget and timelines.
• Act as the primary company contact for trial sites, engaging with investigators and site staff.
• Follow up with sites to ensure investigator engagement and communicate status and issues.
• Drive study compliance by maintaining trial management systems, analyzing trial progress, and initiating corrective actions.
• Contribute to recruitment strategy and contingency planning.
• Manage vendor relationships at the country level, including site and local vendor invoicing and supply management.
• Ensure high standards for study monitoring, including local trial team meetings and training.
• Contribute to patient understanding and safety, including informed consent and AE/SAE reporting.
• Maintain inspection readiness through accurate data and document management.
• Ensure quality data collection and query resolution.
• Stay compliant with training and develop therapeutic knowledge.
• Work with study management to implement CAPA for audits and inspections.
• Ensure accurate financial reporting and trial budget management.
• Organize and ensure regulatory approvals and compliance.
• Potentially contribute as a trainer or process contributor.
• Utilize time reporting effectively.
• Experience in complex early phase trial management.
• Autonomy and depth of knowledge in local trial management services.
• Process leadership.

Requirements

• BA/BS degree in health or science related field.
• 3-5+ years of trial end-to-end management experience.
• Experience with trial startup and database locks/cleaning.
• Solid Tumor Oncology experience.
• Strong knowledge of ICH-GCP, SOPs, local laws, and protocols.
• Proficient in relevant software and systems.
• Fluent in the country language and English.
• Legally authorized to work in the US without sponsorship.

Benefits

• Competitive salary and performance incentives.
• Health and wellbeing programs including medical, dental, and vision.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance and wellbeing resources.
• Learning and development opportunities.

Additional Information

• Employment contingent on legal right to work in the country.
• ICON offers a comprehensive rewards package.
• ICON is an equal opportunity employer and accessible workplace.
• Reasonable accommodations available during recruitment.