Senior Clinical Trial Manager

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

📋 Description

• Act as the main communication liaison for designated trial sites and facilitate collaboration among internal client teams to resolve issues.

• Foster relationships with key site stakeholders and represent their interests to client teams.

• Assist in site feasibility assessments, conduct site qualification visits, follow up, and participate in the final site selection process.

• Organize local team activities, manage recruitment planning, address contingency and risk management, oversee budget forecasting, and maintain study-level documentation.

• Involve investigators and site personnel throughout the trial, relaying status updates and addressing issues with stakeholders.

• Keep trial management systems updated and analyze the progress of trials.

• Initiate corrective and preventive measures when trials diverge from established plans.

• Contribute to the recruitment strategy at the site level and develop contingency plans.

• Oversee country-level vendors, manage invoices, local study supplies, and vendor selection requests.

• Conduct local trial team meetings and provide monitoring training.

• Prepare and manage informed consent forms specific to the country and site.

• Ensure that adverse events, serious adverse events, and product quality complaints are reported within required timeframes.

• Maintain readiness for inspections, manage essential documents, and oversee CTMS and eTMF/IF data, along with archiving records.

• Guarantee site data quality and prompt resolution of queries.

• Support the implementation of CAPA for audits, inspections, and quality visits.

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

• Coordinate IEC/HA approvals with the local Start-Up team.

• Provide training on systems and processes while contributing to process improvement initiatives.

• Complete accurate and timely time reporting.

• Manage complex Early Phase trials in collaboration with internal matrix clinical teams and sites.

⛳️ Requirements

• Bachelor's degree (BA/BS).

• Degree in a health or science-related discipline.

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

• Experience in start-up and database locks/cleaning is preferred.

• Hematology/Oncology experience is required.

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

• Proficient IT skills in relevant software and company systems.

• Fluent in both the local language and English, with good written and verbal communication skills.

• Legally authorized to work in the United States.

• Must not require sponsorship for employment visa status, now or in the future.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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