Sr. Clinical Trial Manager

Akero Therapeutics seeks a Senior Clinical Trial Manager to oversee EMEA region operations for clinical studies focused on metabolic diseases. The role involves coordinating with CROs, managing regulatory submissions, conducting site monitoring visits, and ensuring protocol compliance across European trial sites.

Responsibilities

• Oversee CRO setup and site initiation in EMEA region with global coordination
• Manage day-to-day trial site communications and identify operational issues
• Lead EMEA regulatory submission strategies and regulatory package reviews
• Conduct protocol compliance monitoring visits with CRO clinical research associates
• Coordinate data review and interim/final clinical study report preparation

Requirements

• Clinical trial management experience in pharmaceutical or biopharmaceutical settings
• Knowledge of EMEA regulatory requirements and submission processes
• Experience with CRO vendor management and site coordination
• Proficiency in clinical trial protocols, monitoring plans, and regulatory documentation
• Strong project management and cross-functional collaboration skills
• Ability to conduct site monitoring visits and quality assurance activities