Clinical Trial Manager - Remote

Overview

We are seeking a Clinical Trial Manager (CTM), who will be accountable for the operational management and execution of global clinical trial programs (Phases I-III). The individual will be responsible for ensuring adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution.

In Short

• Oversee study scope, quality, timelines, and budget with internal functional leads, CRO and vendors.
• Initiate and build strong relationships with key opinion leaders and clinical site staff.
• Partner with CRO(s) for patient enrollment strategies.
• Manage study-related risks proactively.
• Develop and manage clinical trial documents.
• Ensure compliance with national and international regulatory requirements.
• Oversee TMF maintenance and ensure completeness.
• Coach Clinical Trial Associates allocated to the project.
• Ensure the study is “inspection ready” at all times.
• Travel globally as needed (up to 25%).

Requirements

• Bachelor’s degree in life science or equivalent.
• 5+ years of clinical project management experience in Respiratory therapeutic area.
• Prior phase II and III experience required.
• Solid understanding of the drug development process and ICH guidelines.
• Experience with budget forecasting and management.
• Proven proficiency in overseeing complex studies.
• Excellent interpersonal and decision-making skills.
• Ability to problem solve and use clear judgment.
• Collaborative team-player.
• Excellent written and oral communication skills.

Benefits

• A great culture grounded in C.O.R.E. values.
• Opportunity to work in a fast-paced, dynamic environment.
• Market competitive compensation and benefits package.
• Flexible PTO.
• Commitment to professional growth and development.