Clinical Trial Manager

The role

The Clinical Trial Manager will perform regional study management for the EU and vendor management. This person will partner on the start-up and initiation of a global Phase 3 program.

What you will do

• Manage day-to-day activities within a region including site selection, start-up, maintenance, and close-out
• Serve as operational contact for studies aiding in site selection, implementation, and coordination
• Assist with oversight of CRO and set-up of vendors
• Act as day-to-day contact with counterparts at CRO and trial sites
• Review site Informed Consent Forms and assist with regulatory submission package review
• Identify potential operational challenges and provide solutions
• Perform accompanied visits with CRO CRAs
• Assist in review of protocols, informed consents, case report forms, and clinical study reports
• Review trip reports, protocol deviations, and data listings
• Maintain internal Clinical Operations databases and document repositories

Required qualifications

• At least 4+ years of relevant experience
• BS or BA in a relevant scientific discipline or an RN (2- or 3-year certificate)
• Relevant clinical trial experience in the pharmaceutical or health care industry
• Excellent attention to detail, interpersonal and presentation skills
• Excellent organizational, problem-solving and time management skills
• Must be familiar with routine medical/scientific terminology
• Must be familiar with Word, PowerPoint, and Excel
• Must be able to participate in departmental or interdepartmental strategic initiatives
• High energy level, personal productivity, creativity and commitment
• Highly adaptable team-player
• Strong written and verbal communication skills
• Ability to thrive in a fast-paced, dynamic environment

Nice to have

• Experience as the regional lead for Europe
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs
• Intermediate or higher excel proficiency

Benefits

• Annual bonus
• Equity
• Comprehensive benefits offering

Before you apply

• Braveheart participates in the federal E-Verify program to confirm employment authorization

About the company

Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases.