Senior Clinical Trial Manager

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee daily clinical trial operations for assigned studies, sites, CROs, laboratories, and vendors.

• Manage study initiation, site activation, monitoring oversight, and closure activities.

• Take ownership of study timelines, budgets, invoices, vendor deliverables, and key milestones.

• Ensure study documentation and trial master file quality to maintain inspection readiness.

• Review and offer operational guidance on clinical documents, including protocols, ICFs, CRFs, SAPs, CSRs, study plans, and associated materials.

• Collaborate with cross-functional study teams to facilitate study execution, address operational challenges, and meet study milestones.

• Handle clinical sample logistics among patients, sites, and laboratory vendors.

• Manage timelines and logistics for Safety Review Boards, Data Monitoring Committees, data cuts, and related study activities.

• Lead or assist in vendor review, selection, contracting, onboarding, and performance management.

• Establish and nurture relationships with investigative sites, CROs, vendors, clinical experts, and internal stakeholders, including organizing investigator meetings.

• Identify, escalate, and mitigate study risks and operational challenges.

• Act as the company representative with study partners and investigative sites.

• Travel domestically and internationally to investigative sites or study-related meetings as necessary.

⛳️ Requirements

• Bachelor’s degree in a scientific, health-related, or relevant field.

• Over 6 years of progressive clinical operations experience in the pharmaceutical and/or biotechnology sector.

• Proven experience managing clinical trial execution from initiation through to completion.

• Background in managing early-phase clinical studies; experience in rare disease or CNS preferred.

• Familiarity with managing U.S. and global clinical trials across CROs, vendors, laboratories, and study sites.

• Knowledge of ethics committee and regulatory submissions such as pre-IND, IND, Scientific Advice, CTA, or similar filings.

• Strong understanding of GCP, ICH guidelines, clinical research regulations, and the drug development process.

• Experience with vendor oversight, budgets, contracts, invoices, and change orders.

• Exceptional clinical operations leadership, project coordination, planning, and organizational abilities.

• Proficiency in Smartsheet, Microsoft Office, or comparable project and study tracking tools.

• Excellent communication skills and the capability to collaborate effectively with internal and external stakeholders.

• Knowledge of mRNA, RNAi, gene therapy, or gene-editing therapeutics; familiarity with LNP or AAV-based development is a plus.

• Ability to work both independently and collaboratively in a fast-paced environment.

• Hands-on approach and readiness to engage across multiple areas of clinical operations in a startup setting.

🏝️ Benefits

• Eligibility for bonuses.

• Equity options for new hires.

• Comprehensive health coverage.

• Discretionary paid time off.

• Fully remote position.