Note: The job is a remote job and is open to candidates in USA. Arbor Biotechnologies is hiring a Senior Clinical Trial Manager to lead day-to-day operations for assigned early-phase gene-editing studies in rare genetic diseases. The role oversees study execution from start-up through close-out, including sites, CROs and vendors, documentation, timelines, budgets, and operational issue resolution.

Responsibilities

• Lead day-to-day clinical trial operations across assigned studies, sites, CROs, laboratories, and vendors
• Manage study start-up, site activation, monitoring oversight, and close-out activities
• Own and manage study timelines, budgets, invoices, vendor deliverables, and key milestones
• Oversee study documentation and trial master file quality to support inspection readiness
• Review and provide operational leadership on clinical documents, including protocols, ICFs, CRFs, SAPs, CSRs, study plans, and related materials
• Partner with cross-functional study teams to drive study execution, resolve operational issues, and support achievement of study milestones
• Manage clinical sample logistics between patients, sites, and laboratory vendors
• Drive timelines and logistics for Safety Review Boards, Data Monitoring Committees, data cuts, and related study activities
• Lead or support vendor review, selection, contracting, onboarding, and performance oversight
• Build and manage effective relationships with investigative sites, CROs, vendors, clinical experts, and internal stakeholders, including planning investigator meetings
• Identify, escalate, and resolve study risks and operational issues
• Represent the company externally with study partners and investigative sites
• Travel domestically and internationally to investigative sites or study-related meetings as needed

Skills

• Bachelor's degree in a scientific, health-related, or related field
• 6+ years of progressive clinical operations experience in the pharmaceutical and/or biotechnology industry, including experience managing clinical trial execution from start-up through close-out
• Experience managing early-phase clinical studies
• Experience managing U.S. and global clinical trials across CROs, vendors, laboratories, and study sites
• Familiarity with ethics committee and regulatory submissions, such as pre-IND, IND, Scientific Advice, CTA, or similar filings
• Strong knowledge of GCP, ICH guidelines, clinical research regulations, and the drug development process
• Experience with vendor oversight, budgets, contracts, invoices, and change orders
• Strong clinical operations leadership, project coordination, planning, and organizational skills
• Proficiency with Smartsheet, Microsoft Office, or similar project and study tracking tools
• Clear communication skills and the ability to work effectively with internal and external stakeholders
• Knowledge of mRNA, RNAi, gene therapy, or gene-editing therapeutics
• Ability to work independently and collaboratively in a fast-paced environment
• Hands-on mindset and willingness to work across multiple areas of clinical operations in a startup environment
• Rare disease or CNS experience preferred
• Familiarity with LNP or AAV-based development preferred

Benefits

• Every employee is eligible for a bonus and new hire equity.
• The company pays about 90% of medical, dental, and vision premiums.
• The company funds the full deductible on its HSA plan.
• 12 weeks of parental leave at full pay.
• Paid parking or transit.
• A 401(k) match.
• Discretionary time off.

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