Senior Clinical Trial Manager Consultant (CF Program) East Coast

$156,000 - $187,200/Yr

Recode Therapeutics - Menlo Park, CA

Full-time - Senior

Remote - Menlo Park, CA

Chemical Manufacturing

About the position

The Senior Clinical Trial Manager Consultant will lead the clinical operations strategy for ReCode Therapeutics' RCT2100 CF program. This role involves managing all aspects of clinical trial startup and conduct, collaborating with cross-functional teams, and ensuring optimal relationships with clinical sites and stakeholders. The position requires substantial experience in rare diseases or genetic medicines, particularly in managing Phase 1-3 clinical trials.

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.
• Develop and execute activities outlined in various study plans including sponsor oversight, monitoring, deviation, training, and study 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.
• Participate in supporting program team on key regulatory filings as needed.
• Manage and collaborate with CROs and other study vendors.
• Support Study Execution Team meetings.

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 in rare disease clinical trials.
• Working knowledge of study startup timelines/management and study conduct in the European region for ultra 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.
• Strong understanding of rare disease patient recruitment and site/patient engagement strategies.
• Excellent communication and interpersonal skills with the ability to collaborate in a fast-paced environment.

Nice-to-haves

• Rare disease/orphan drug experience preferred.
• Highly responsive and proactive team player.
• Ability to have a growth mindset when problem solving complex issues.
• Strong organizational skills and able to prioritize multiple ongoing projects.

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.