Senior Clinical Trial Manager Consultant

4 weeks ago

Menlo Park, California, United States ReCode Therapeutics, Inc Full time
Job Summary

We are seeking an experienced and dynamic Senior Clinical Trial Manager Consultant to join our team at ReCode Therapeutics, Inc. As a key member of our Clinical Operations team, you will be responsible for implementing global clinical operations strategy for our RCT2100 CF program. Your expertise in rare diseases and genetic medicines will be invaluable in driving the success of our mission to power the next wave of genetic medicines.

Key Responsibilities
  • 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 internal and external teams on track.
  • Liaise with clinical site staff and Investigators to ensure optimal Sponsor-site relationships and drive clinical trial recruitment activities.
  • Develop and ensure execution of 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 independently resolve issues and escalate challenges/obstacles effectively.
  • Participate in supporting program team on key regulatory filings, such as US IND, EU CTIS, and UK MHRA.
  • Experience managing and collaborating with CROs and other study vendors.
Qualifications
  • BS/BA required with 7+ years of Clinical Operations experience in biotech/pharma managing Phase 1-3 clinical trials.
  • Rare disease or 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 the US region in rare disease indications.
  • Track record of success in negotiating with CROs and representing the sponsor to internal and external stakeholders.
  • Demonstrated knowledge of ICH GCP and thorough knowledge of clinical monitoring procedures.
  • Broad vendor management experience with CROs and core clinical trial vendors.
  • Strong understanding and experience in rare disease patient recruitment and site/patient engagement strategies.
  • Highly responsive and proactive team player.
  • Ability to have a 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.
Benefits
  • No premium cost for employees - 100% subsidized by ReCode Therapeutics 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 and their families.
  • FSA available, including a lifestyle spending account subsidized by the company.
  • Employee discounts at hotspots.

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