Remote 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 to deliver on the company's mission of powering genetic medicines.

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 US region in 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
• Broad Vendor management experience with CROs and core clinical trial vendors (imaging, home health, patient concierge, patient recruitment vendors)
• Strong understanding/experience in rare disease patient recruitment and site/patient engagement strategies

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 and drive clinical trial recruitment activities
• 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, EU CTIS, UK MHRA) as needed

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