Senior Clinical Trial Manager Consultant

Summary

Join ReCode Therapeutics as a Senior Clinical Trial Manager Consultant to lead global clinical operations strategy for the RCT2100 CF program, collaborating with cross-functional teams and managing all aspects of clinical trial startup and conduct.

Requirements

• BS/BA required with 7+ years of Clinical Operations experience in biotech/pharma managing Phase 1-3 clinical trials
• Rare disease/orphan drug experience preferred
• Proven track record as Clinical Trial Manager (Global Study Lead experience preferred) in rare disease clinical trials
• Working knowledge of study startup timelines/management and study conduct in European region in ultra rare disease indications
• Track record of success in negotiating with CROs and representing the sponsor to internal and external stakeholders (ie site/vendor relationships)
• Demonstrated knowledge of ICH GCP and thorough knowledge of clinical monitoring procedures
• Strong understanding/experience in rare disease patient recruitment and site/patient engagement strategies
• Highly responsive and proactive team player
• Ability to have growth mindset when problem solving complex issues
• Strong organizational skills and able to prioritize and manage multiple ongoing projects simultaneously
• Excellent communication and interpersonal skills with the ability to collaborate and work effectively in a cross-functional, fast-paced environment
• Champion for change within a fast-growing company/department
• Positive attitude with an emphasis on team-based problem-solving approach
• Ability to travel for periodic site initiation visits, and co-monitoring visits

Responsibilities

• Independently/proactively manage all aspects clinical trial startup/conduct including CROs, vendors, and key stakeholders
• Accountable for clinical operations startup timelines and working closely with CF Clinical Operations Program Lead to keep internal/external teams on track
• Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
• Develop and ensure execution of activities outlined in various study plans (sponsor oversight, monitoring, deviation, training, and study communication plans)
• Co-monitor or monitor studies if needed for the program
• Drive communication and escalate issues to CF Clinical Operations Program Lead and Head of Clinical Operations
• Navigate team structure (Study execution meeting and clinical meetings) and decision makers to independently resolve issues and escalate challenges/obstacles effectively
• Participate in supporting program team on key regulatory filings (e.g. US IND, UK MHRA, EU CTIS, etc) as needed
• Experience managing/collaborating with CROs and other study vendors
• Support Study Execution Team meetings

Benefits

• No premium cost for employees - 100% subsidized by ReCode for full-time employees
• Company 401k contribution
• 15 days of company paid holidays, including a holiday shutdown (usually the last week of the year)
• Mental health support for employees & their families
• FSA available, including a lifestyle spending account subsidized by company
• Employee discounts at hotspots