Senior Clinical Trial Manager

Astria Therapeutics, Inc. - Boston, MA

Full-time - Senior

Boston, MA

About the position

The Senior Clinical Trial Manager at Astria Therapeutics plays a crucial role in managing clinical studies across various phases, ensuring the efficient conduct of patient trials in the company's clinical research programs. This position involves overseeing day-to-day clinical study activities, including the development of study materials, regulatory filings, and collaboration with study teams and CROs. The role requires a strong focus on compliance with GCP guidelines and effective communication with study sites to resolve issues proactively.

Responsibilities

• Lead and support clinical study activities in partnership with Clinical Trial Associates, study teams, and CROs.
• Manage all aspects of study progress from start-up to close-out, ensuring adherence to timelines and compliance with GCP guidelines.
• Provide operational oversight and guidance to prioritize activities and develop contingency plans.
• Coordinate interdisciplinary activities for study start-up, including investigator meetings and regulatory document filing.
• Prepare and review study-related documents and site-specific materials.
• Oversee and manage CROs to ensure successful trial conduct and data integrity.
• Communicate with study sites to recognize and resolve problems proactively.

Requirements

• Bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or related field.
• 5+ years of clinical research experience in industry settings, with at least 3 years managing clinical trials.
• Experience with phase III and large global studies, managing submission timelines and processes.
• Demonstrated ability to identify emerging risks and collaboratively resolve challenges within a drug development team.
• Solid project and vendor management skills, along with analytical and problem-solving abilities.
• Knowledge of GCP/ICH Guidelines for clinical studies.
• Ability to work independently in a fast-paced environment.
• Excellent verbal and written communication skills.
• Competent computer skills, including Microsoft Office and familiarity with clinical systems.