Senior Clinical Trial Manager

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

📋 Description

• Act as a site-aligned partner throughout the entire trial lifecycle.

• Enhance communication among cross-functional stakeholders and support issue resolution.

• Serve as the main contact for assigned trial sites, engaging with investigators and site personnel.

• Contribute to site feasibility assessments, site qualification visits, site selection, recruitment strategies, contingency planning, and execution.

• Coordinate activities for local/country teams, including recruitment targets, study documentation, procedures, tools, risk management, and budget forecasting.

• Oversee trial management systems, monitor trial progress, initiate CAPA as needed, and communicate study statuses and issues.

• Manage country-level vendors, their services, selection processes, and site/local vendor invoicing.

• Handle local study supplies when necessary.

• Conduct meetings for local trial teams and facilitate study-monitoring training sessions.

• Prepare and manage informed consent forms specific to countries and sites.

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

• Maintain readiness for inspections, complete trial data and essential documents in CTMS and eTMF/IF, and assist with archiving processes.

• Guarantee data quality at sites and resolve queries promptly.

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

• Ensure precise financial reporting and adherence to budget constraints, including local budget forecasting and management.

• Assist in contract and budget negotiations for trial sites when necessary.

• Organize and secure IEC/HA approvals with the local Start-Up team.

• Provide training on systems/processes and contribute to process initiatives as needed.

• Complete time reporting accurately and promptly.

• Manage complex Early Phase trials alongside internal matrix clinical teams and sites when applicable.

⛳️ Requirements

• BA/BS degree.

• Degree in a health or science-related discipline.

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

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

• Experience in Solid Tumor Oncology is required.

• 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 the country’s language and English, both spoken and written.

• Excellent written and verbal communication skills.

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

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellbeing resources.

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

• Reasonable accommodations during the recruitment process.

• An inclusive and accessible workplace.