Senior Clinical Trial Manager

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

📋 Description

• The Senior LTM position is responsible for guaranteeing high-quality end-to-end trial delivery at the country level, overseeing the uniformity of Local Trial Management responsibilities and processes.

• The Senior LTM acts as the primary contact at the country level for internal partners regarding the study.

• They function as a site-aligned end-to-end partner, facilitating communication among cross-functional stakeholders throughout the lifecycle of trials.

• Serves as the main communication channel for sites, promoting collaboration among internal clients to resolve issues effectively.

• Possesses a deep understanding of the site operational model and maintains relationships with essential site stakeholders, representing the site's interests to the client's teams.

• Functions as the Principal Local Operations Manager: a trial-aligned member of the CFTT responsible for USA-level accountability, acting as the "quarterback" for Local Operations Managers and conveying a unified voice to the global team.

• The Senior LTM will manage and oversee the following throughout the study: Central IRB and other local vendors.

• Execution of local milestones from feasibility through to study closure.

• Allocation of country-level roles, including assistance with transitions, in collaboration and agreement with the study Functional Manager (FM).

• Ensures Inspection Readiness and AQR at the country level.

• Collaborates closely with the assigned Local Trial Manager(s) (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to define accountabilities/responsibilities and provide necessary support and training.

• Maintains effective communication with Clinical Trial Managers (CTMs), Clinical Operations, and the Global Trial Leader (GTL) to ensure trial excellence.

• Organizes country-level ad hoc meetings during any study phase to address unforeseen circumstances that may impact country or study-level deliverables.

• Works in close partnership with the study FM to provide updates, discuss challenges, timelines/resources, and potential risks, and assist with any documentation needed by leadership.

• Operates autonomously in executing local trial management services.

• Demonstrates a comprehensive understanding of local trial management services.

⛳️ Requirements

• Bachelor's degree (BA/BS).

• Degree in a health or science-related field.

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

• Experience with Start-up & Database Locks/Cleaning preferred.

• Required experience in Solid Tumor and/or Hematology Oncology.

• Strong working knowledge 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.

• Willingness to travel, including occasional overnight stays away from home, as needed for business.

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

• Must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status.

🏝️ Benefits

• Various annual leave entitlements.

• A range of health insurance options to cater to you and your family’s needs.

• Competitive retirement planning solutions to enhance savings and ensure confidence for the future.

• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to a worldwide network of over 80,000 independent specialized professionals dedicated to supporting you and your family’s well-being.

• Life assurance coverage.

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.