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.

• Serve as the main communication point for assigned trial sites, investigators, and site personnel.

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

• Lead and coordinate activities within the local team to achieve recruitment targets, ensure data quality, adhere to timelines, and stay within budget.

• Develop local trial procedures and tools, recruitment strategies, contingency measures, risk management plans, and budget forecasts.

• Maintain investigator engagement and convey trial status and issues to stakeholders.

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

• Initiate corrective and preventive actions when trials deviate from established plans.

• Contribute to the recruitment strategy at the site level and assist in contingency planning.

• Manage country-level vendors, invoicing, vendor selection, and local study supplies.

• Conduct local trial team meetings and provide study-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 the necessary timelines.

• Maintain readiness for inspections by ensuring complete and accurate trial data and essential documents in CTMS and eTMF/IF.

• 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 trial budgets.

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

• Provide training or contribute to process initiatives when relevant.

• Complete time reporting accurately and in a timely manner.

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

⛳️ Requirements

• Bachelor's or Master's degree.

• Degree in a health or science-related field.

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

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

• HemOnc 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 country language and English, with excellent written and verbal communication skills.

• Legally authorized to work in the United States.

• Must not require current or 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 insurance and disability coverage.

• Employee assistance programs and wellness resources.

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