Senior Clinical Trial Manager

Job not on LinkedIn

🔥 15 minutes ago

🍂 Massachusetts – Remote

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💵 $165k - $185k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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👻 Ghost score 0%

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Logo of Arbor

Arbor

11 - 50 employees

🛍️ eCommerce

eCommerce

Arbor is a Home Improvements Technology Startup. The company is focused on revolutionizing the way consumers shop for home improvements by integrating software, artificial intelligence, and human insights. Arbor aims to enhance the online shopping experience in the home improvement sector, believing that a superior shopping experience can lead to an improved quality of life.

📋 Description

• 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 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

🎯 Requirements

• 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 • 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 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

🏖️ Benefits

• Bonus eligibility • New hire equity • Comprehensive health coverage • Discretionary paid time off • Fully remote role

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