Senior Clinical Trial Manager

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Act as an end-to-end partner aligned with site operations throughout the lifecycle of trials, facilitating clear communication among cross-functional stakeholders.

• Serve as the main contact for designated trial sites, ensuring engagement with investigators and site staff.

• Participate in site feasibility assessments, conduct site qualification visits, and contribute to follow-up reporting and the final selection of sites.

• Organize activities for local and country teams to achieve recruitment goals, deliver high-quality data punctually, and adhere to budget constraints.

• Create plans for recruitment, manage contingencies and risks, develop local procedures, tools, and budget forecasts.

• Oversee trial management systems and assess reports to enhance study compliance and track trial progress.

• Proactively initiate and relay corrective and preventive actions when there are deviations from trial plans.

• Supervise country-level vendors, their services, selection processes, and relevant invoice management.

• Manage local study supplies as necessary.

• Conduct local trial team meetings and provide monitoring training as required.

• Prepare and oversee country- and site-specific informed consent documents.

• Ensure timely reporting of adverse events, serious adverse events, and product quality complaints as mandated.

• Maintain accurate, complete, and timely trial data and essential documents within CTMS and eTMF/IF systems, keeping them inspection-ready.

• Highlight issues related to deviations and ensure the quality of site data along with query resolution.

• Assist in the implementation of Corrective and Preventive Actions (CAPA) for audits, inspections, and quality-related visits.

• Ensure precise financial reporting, forecasting of country/local budgets, and proactive management of budgets.

• Aid in negotiations regarding trial site contracts and budgets when necessary.

• Coordinate and ensure approvals from the IEC/HA in collaboration with the local Start-Up team.

• Offer training on systems and processes, contributing to process improvement initiatives when applicable.

• Complete accurate and timely time reporting.

• Manage and initiate complex Early Phase trials alongside internal matrix clinical teams and sites, as needed.

⛳️ Requirements

• Bachelor's degree in a health or science-related discipline.

• 3–5+ years of comprehensive trial management experience.

• Experience with start-up processes and database locking/cleaning is preferred.

• Required experience in Solid Tumor Oncology.

• Strong understanding of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols, and protocol-specific procedures.

• Proficient IT skills in relevant software and company systems.

• Fluent in both the local language and English, with strong written and verbal communication abilities.

• Legally permitted to work in the United States.

• Must not require current or future sponsorship for employment visa status.

• Must adhere to relevant training requirements and acquire sufficient therapeutic knowledge for the role.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.

• An inclusive and accessible workplace.

• Reasonable accommodations during the recruitment process.