Senior Clinical Trial Manager

Arbor Biotechnologies; United States; Remote; USD 165,000 - 185,000; Full time

Benefits offered by this job

Bonus eligibility

New hire equity

Comprehensive health coverage

Discretionary paid time off

Job summary

Arbor Biotechnologies is seeking a Senior Clinical Trial Manager to lead day‑to‑day operations for early‑phase gene-editing programs in rare genetic diseases. You will oversee start‑up through close‑out, manage sites, CROs, vendors, timelines, and budgets, and ensure documentation and inspection readiness, while partnering with internal and external teams.

The role requires hands‑on leadership, collaboration across multiple functions, and global trial oversight, including regulatory submissions

Qualifications

• Bachelor’s degree in a scientific, health-related, or related field.
• 6+ years of progressive clinical operations experience in pharma/biotech, including start‑to‑close trial execution.
• Experience managing early‑phase studies; rare disease or CNS experience preferred.
• Experience managing U.S. and global trials across CROs, vendors, labs, and sites.
• Familiarity with ethics committee and regulatory submissions (pre‑IND/IND/CTA or similar).
• Strong knowledge of GCP, ICH guidelines, and drug development processes.
• Experience with vendor oversight, budgets, contracts, invoices, and change orders.
• Strong clinical ops leadership, planning, and organizational skills.
• Knowledge of mRNA, RNAi, gene therapy or gene‑editing therapeutics; LNP/AAV familiarity preferred.
• Ability to work independently and collaboratively in a fast-paced startup environment.

Responsibilities

• Lead day-to-day clinical trial operations across studies, sites, CROs, labs, and vendors.
• Manage start‑up, site activation, monitoring oversight, and close‑out activities.
• Own and manage study timelines, budgets, invoices, vendor deliverables, and milestones.
• Oversee study documentation and trial master file quality for inspection readiness.
• Review operational documents such as protocols, ICFs, CRFs, SAPs, CSRs, and study plans.
• Partner with cross-functional teams to drive execution and milestones.
• Manage clinical sample logistics between patients, sites, and labs.
• Drive timelines for Safety Review Boards, DMCs, data cuts, and related activities.
• Lead or support vendor review, contracting, onboarding, and oversight.
• Build relationships with sites, CROs, vendors, and internal stakeholders; plan investigator meetings.
• Identify and mitigate study risks and operational issues.
• Represent the company externally with study partners and sites.
• Travel domestically and internationally as needed.

Skills

Clinical trial operations leadership

Project coordination

Planning and organizational skills

Communication skills

Stakeholder management

Smartsheet or Office proficiency

Education

Bachelor’s degree in a scientific/health-related field

Tools

Smartsheet

Microsoft Office

Job description

About the role.

The Senior Clinical Trial Manager will lead day-to-day clinical trial operations for assigned early-phase studies of our gene-editing therapeutics in rare genetic diseases. Reporting to the Senior Director of Clinical Operations, this role will be 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.

In our lean biotech environment, this role requires a hands‑on clinical operations leader who can manage multiple aspects of trial execution while partnering closely with internal teams, investigative sites, CROs, laboratories, and external vendors.

What you’ll do.

• 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.

What you bring.

• 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; rare disease or CNS experience preferred.
• 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; familiarity with LNP or AAV‑based development preferred.
• 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.

Fully remote role

Compensation and benefits.

The anticipated base salary range for this position is $165,000–$185,000. Actual compensation will be determined based on several factors, including relevant experience, skills, education, training, internal equity and other job‑related factors. All employees are eligible for bonus, new hire equity, comprehensive health coverage, and discretionary paid time off.

Arbor is an equal opportunity employer. We’re committed to a hiring process and a workplace free of bias and discrimination, and we welcome candidates of every background.