Local Trial Manager - Oncology

About This Role

This role will be accountable for ensuring high-quality end-to-end trial delivery at a country level, managing consistency of Local Trial Management duties and processes. The Local Trial Manager will serve as the country-level single point of contact for internal partners on oncology studies.

Responsibilities

• Manage and oversee Central IRB and other local vendors (Greenphire, Drug Destruction services), including set up of purchase orders, invoice review, approval, and change-orders.
• Execute local milestones from feasibility through study close out.
• Resource country-level roles, including support with transitions, in collaboration with the study Functional Manager.
• Ensure Inspection Readiness and AQR at the country level.
• Collaborate closely with assigned Local Trial Manager(s), Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers to outline accountabilities/responsibilities and provide support and training.
• Communicate efficiently with Clinical Trial Managers, Clinical Operations, and the Global Trial Leader to oversee trial excellence.
• Attend country level ad hoc meetings during any phase of the study to address unexpected circumstances impacting deliverables.
• Partner closely with the study FM to provide updates, discuss hurdles, timelines/resources, potential risks, and assist with documentation.

Requirements

• 2 years of local trial management or mutually agreed clinical trial experience
• Oncology Solid Tumor experience
• Strong working knowledge of ICH-GCP, company SOPs, local laws and regulations, assigned protocols and procedures
• Proficient in speaking and writing the country language and English
• Legally authorized to work in the United States without future sponsorship for employment visa status

Qualifications

• BA/BS degree in a health or science related field
• 2 years of local trial management or mutually agreed clinical trial experience.

Nice to Have

• Start-up & Database Locks/Cleaning experience
• LTM experience in Lupus/GI

Benefits