Senior Clinical Trial Manager

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

📋 Description

• Act as a site-aligned end-to-end partner throughout the lifecycle of trials.

• Serve as the main point of contact for designated trial sites and facilitate collaboration among internal client teams to resolve issues.

• Manage relationships with key site stakeholders and advocate for sites within client teams.

• Assist in site feasibility assessments, site qualification visits, follow-ups, and final site selection.

• Coordinate local team efforts to achieve recruitment targets, ensure high-quality data, and adhere to budget and compliance requirements.

• Involve investigators and site personnel throughout the trial and relay status updates and issues to stakeholders.

• Maintain and regularly update trial management systems while analyzing trial progress.

• Initiate Corrective and Preventive Actions (CAPA) when trials diverge from established plans, and report progress and issues to study management and Quality & Compliance teams.

• Contribute to the development of site-level recruitment strategies, contingency plans, and their implementation.

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

• Lead local trial team meetings and provide monitoring training as necessary.

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

• Ensure that Adverse Events (AEs), Serious Adverse Events (SAEs), and Protocol Deviations (PQC) are reported within required timelines.

• Maintain inspection readiness through timely and complete trial data and essential documents in Clinical Trial Management Systems (CTMS) and electronic Trial Master Files (eTMF/IF).

• Ensure data quality from sites and prompt resolution of queries.

• Keep up-to-date with therapeutic knowledge and fulfill relevant training obligations.

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

• Ensure accurate financial reporting, budget forecasting, and proactive management of country/local trial budgets.

• Organize and secure approvals from Independent Ethics Committees (IEC) and Health Authorities (HA) with the local Start-Up team.

• Participate in systems/process training and functional process initiatives.

• Submit timely and precise time reports.

• Oversee complex Early Phase trial start-up and projections with internal matrix clinical teams and sites as necessary.

• Execute local trial management services independently and provide process leadership.

⛳️ Requirements

• Bachelor's degree (BA/BS).

• Degree in a health or science-related field.

• 3 to 5+ years of experience in end-to-end trial management.

• Experience with Start-up & Database Locks/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 related protocol-specific procedures.

• Proficient IT skills in relevant software and company systems.

• Fluent in both the country language and English, with strong written and verbal communication skills as necessary.

• Legally authorized to work in the United States.

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

🏝️ 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 assurance and disability coverage.

• Employee assistance programs and wellness resources.

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