Senior Clinical Trial Manager - Remote

Overview

The Senior Clinical Trial Manager is a senior leader accountable for overall clinical study operations including CRO and vendor management, development of project plans, budget, and resource management.

In Short

• Performs job with minimal supervision
• Acts as the clinical operations representative in a variety of cross-functional teams
• Collaborates with the program Clinical Operations Lead to develop and manage study level timelines and budgets
• Independently manage clinical study vendors
• Establish key deliverables and KPIs in management of CRO and vendors
• Collaborate with CRO to identify and develop training needs for site staff
• Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees
• Develop clinical monitoring strategies for assuring study timelines are met
• Manage study activities including investigator selection and subject recruitment
• Provide direction and mentoring to junior team members

Requirements

• Bachelor’s degree required, preferably in the Life Sciences
• Minimum of 5+ years of experience in clinical operations
• Experience managing a CRO and complex studies
• Global Clinical Trial experience in Phase 2 and/or Phase 3 preferred
• Exceptional attention to detail and organizational skills
• Excellent communication and project management skills
• Ability to develop and maintain strong relationships with stakeholders
• Ability to multi-task and work in a fast-paced environment
• In-depth knowledge of ICH/GCP and regulatory guidelines
• Team leadership experience within a cross-functional matrix environment

Benefits

• The base salary range for this role is $171,000-$189,000.
• Avidity offers competitive compensation and benefits, including annual bonuses and stock options.
• Comprehensive wellness program including medical, dental, vision, and LTD coverage.
• Four weeks of time off.
• Commitment to learning and development with various training opportunities.