Clinical Trial Manager II

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

📋 Description

• The Senior LTM position will be responsible for ensuring high-quality end-to-end trial execution at the country level.

• Overseeing the consistency of Local Trial Management responsibilities and procedures.

• The Senior LTM will act as the primary point of contact for internal partners regarding the study at the country level.

• Although the Sr LTM may delegate tasks to other LTMs or team members involved in the study, they remain responsible for the successful completion of those tasks.

• The Sr LTM will manage and supervise various aspects throughout the study, including Central IRB and other local vendors, vendor purchase order setups, invoice reviews and approvals, and change orders as necessary.

• Implementing local milestones from feasibility through to study closure.

• Facilitating the resourcing of country-specific roles, including support during transitions, in collaboration with the study Functional Manager (FM).

• Ensuring inspection readiness and AQR at the country level.

• Collaborating closely with assigned Local Trial Managers, Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers to clarify accountabilities/responsibilities and provide support and training when needed.

• Maintaining effective communication with Clinical Trial Managers, Clinical Operations, and the Global Trial Leader to promote trial excellence.

• Conducting country-level ad hoc meetings during any phase of the study to address unexpected circumstances that may affect country or study-level deliverables.

• Working closely with the study FM to provide updates, discuss challenges, timelines/resources, and potential risks, while assisting with documentation such as storyboards, lessons learned, metrics, etc., that may be required by leadership.

• Exercising autonomy in the execution of local trial management services.

• Possessing an in-depth knowledge of local trial management services.

• Demonstrating process leadership.

⛳️ Requirements

• BA/BS degree.

• Degree in a health or science-related discipline.

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

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

• Experience in Oncology Solid Tumor is required.

• Specific therapeutic area experience may be necessary based on the role.

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

• Proficient IT skills in relevant software and company systems.

• Willingness to travel with occasional overnight stays away from home based on business requirements.

• Proficient in both the local language and English, with strong written and oral communication skills as appropriate.

• Applicants 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 meet you and your family’s needs.

• Competitive retirement planning offerings to enhance savings and plan confidently for the future.

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

• Life assurance.

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