Senior Clinical Trial Manager
Arbor Biotechnologies
•$165,000 - $185,000•Remote
About The Position
The Senior Clinical Trial Manager will lead day-to-day clinical trial operations for assigned early-phase studies of gene-editing therapeutics in rare genetic diseases. Reporting to the Senior Director of Clinical Operations, this hands-on role is responsible for study execution from start-up through close-out, including site oversight, CRO and vendor management, trial documentation, timelines, budgets, and operational issue resolution. The role works closely with internal teams, investigative sites, CROs, laboratories, and external vendors in a lean biotech environment. The position can be remote.
Requirements
- Bachelor’s degree in a scientific, health-related, or related field.
- At least 6 years of progressive clinical operations experience in the pharmaceutical and/or biotechnology industry, including managing clinical trial execution from start-up through close-out.
- 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 ability to work effectively with internal and external stakeholders.
- 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.
Nice To Haves
- Experience managing early-phase clinical studies; rare disease or CNS experience is preferred.
- Knowledge of mRNA, RNAi, gene therapy, or gene-editing therapeutics.
- Familiarity with LNP- or AAV-based development.
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 clinical documents and provide operational leadership on 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 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.
Benefits
- Bonus eligibility for every employee.
- New-hire equity.
- Company pays about 90% of medical, dental, and vision premiums.
- Full deductible funding on the HSA plan.
- 12 weeks of parental leave at full pay.
- Paid parking or transit.
- 401(k) match.
- Discretionary time off.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
