Senior Clinical Trial Manager Consultant (CF Program)

$156,000 - $187,200/Yr

Recode Therapeutics - Menlo Park, CA

Full-time - Senior

Onsite - Menlo Park, CA

Chemical Manufacturing

About the position

The Senior Clinical Trial Manager Consultant will lead and manage the clinical operations strategy for ReCode Therapeutics' RCT2100 CF program. This role involves collaborating with cross-functional teams to ensure the successful execution of clinical trials focused on genetic medicines, particularly for cystic fibrosis. The ideal candidate will have extensive experience in clinical trial management, particularly in rare diseases or genetic therapies, and will be responsible for overseeing all aspects of trial startup and conduct.

Responsibilities

• Independently manage all aspects of clinical trial startup and conduct, including CROs, vendors, and key stakeholders.
• Accountable for clinical operations startup timelines and work closely with the CF Clinical Operations Program Lead to keep teams on track.
• Liaise with clinical site staff and Investigators to ensure optimal Sponsor-site relationships and drive recruitment activities.
• Develop and execute activities outlined in various study plans, including sponsor oversight, monitoring, deviation, training, and communication plans.
• Co-monitor or monitor studies as needed for the program.
• Drive communication and escalate issues to the CF Clinical Operations Program Lead and Head of Clinical Operations.
• Navigate team structure and decision makers to resolve issues and escalate challenges effectively.
• Support program team on key regulatory filings as needed.
• Manage and collaborate with CROs and other study vendors.

Requirements

• BS/BA required with 7+ years of Clinical Operations experience in biotech/pharma managing Phase 1-3 clinical trials.
• Proven track record as Clinical Trial Manager, with Global Study Lead experience preferred.
• Working knowledge of study startup timelines and management in the US region for rare disease indications.
• Experience negotiating with CROs and representing the sponsor to internal and external stakeholders.
• Demonstrated knowledge of ICH GCP and clinical monitoring procedures.
• Broad vendor management experience with CROs and core clinical trial vendors.
• Strong understanding of rare disease patient recruitment and site engagement strategies.
• Excellent communication and interpersonal skills.

Nice-to-haves

• Rare disease/orphan drug experience preferred.
• Experience in managing clinical trials for genetic medicines such as mRNA, gene therapy, or gene editing.

Benefits

• 100% health insurance premium subsidized for full-time employees.
• Company 401k contribution.
• 15 days of company paid holidays, including a holiday shutdown.
• Mental health support for employees and their families.
• FSA available, including a lifestyle spending account subsidized by the company.
• Employee discounts at hotspots.