Full-Time Senior Clinical Trial Manager

Senior Clinical Trial Manager (Sr CTM)

Oversees all operational aspects of assigned cell-therapy clinical trials, from setup to final report.

Responsibilities

• Trial-level oversight and leadership in cross-functional environment.
• In-depth understanding of trial protocol and procedures, sharing best practices, making recommendations, and providing training.
• Developing vendor and site relationships.
• Developing recruitment and slot management strategies.
• Leading meetings (internal, vendor, investigator) and providing regular updates on trial status.
• Risk identification, mitigation, and management.
• CTMS and eTMF management for compliance and inspection readiness.
• Reviewing EDC design specifications, participation in user acceptance testing, contributing to plans and guidelines.
• Reviewing clinical data for timely entry and data review meetings.
• Reviewing clinical monitoring reports for timely completion and issues.
• Completing and maintaining internal trial metrics and updates.
• Ensuring trials comply with Outpace Bio and ICH/GCP standards.
• Coordinating tasks with other roles for site readiness and trial materials/drug shipping.

Qualifications

• Bachelor's Degree or ex-US equivalent.
• 6+ years clinical research experience, including 3+ years trial management.
• Robust oncology experience, including early-stage, cell or gene therapy (e.g., CAR-T).
• Strong analytical and critical thinking skills.
• Excellent organizational and time management skills, attention to detail.
• Ability to work independently and in a fast-paced environment.
• Good understanding of FDA and ICH GCP guidelines.
• Excellent verbal and written communication skills.

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