SAB BIO · 11 hours ago
Clinical Trial Manager, Immunology
Miami Beach, FL
Full-time
Onsite
Senior Level
6+ years expSAB BIO is a biotechnology company seeking a Clinical Trial Manager to oversee the planning, implementation, and management of clinical trials in immunology. The role involves coordinating cross-functional teams, managing budgets and timelines, and ensuring compliance with regulatory guidelines for successful trial execution.
BiotechnologyClinical TrialsTherapeutics
Responsibilities
Lead the design and implementation of clinical trial protocols, including site selection, patient recruitment strategies, and timeline development
Contributing to the development of study protocols, protocol amendments, study manuals, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Investigator Brochures (IBs) and other study-related documents as require
Oversee implementation and maintenance of Trial Master File for inspection readiness
Manage all aspects of clinical trial operations, ensuring adherence to timelines, budgets, and regulatory requirements
Participate in the identification, evaluation, selection, and oversight of clinical trial sites in collaboration with the Clinical Research Organization (CRO)
Manage external vendors with oversight of activities
Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations
Collaborate with cross-functional teams including clinical research associates, data managers, and regulatory affairs to ensure successful trial execution
Establish and maintain strong relationships with clinical trial sites. Provide ongoing support and oversight to ensure compliance with protocol and regulatory standards
Monitor trial progress, ensuring accurate data collection, timely reporting, and adherence to Good Clinical Practice (GCP) guidelines
Identify potential study risks and develop mitigation strategies to ensure successful trial outcomes
Prepare and present updates to stakeholders, including internal teams and external partners. Facilitate regular meetings to discuss study progress and address challenges
Qualification
Required
B.S. degree with minimum 6-8+ years of experience managing clinical trials in biotech, pharmaceutical
Strong clinical study conduct experience from start-up through close-out, with global trial and CRO management experience
Experience with phase II, III study oversight and management
Experience with timeline management
Strong leadership, effective decision making, and problem-solving skills required
Document reviews in relevant systems with a focus on inspection readiness
Working knowledge of relevant GCPs and FDA, EMA and MHRA regulations
Demonstrated experience using various EDC, CTMS and eTMF (Veeva, Agatha) systems. Experience with operational financial tracking systems a plus
Demonstrated proficiency using MS Office applications, including MS Word, Excel, PowerPoint
Experience using Smartsheet
Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials
Excellent written and verbal communication skills
Preferred
Prefer candidates located in Central or Eastern Time Zones
Company
SAB BIO
A clinical-stage biopharmaceutical company with a novel immunotherapy platform that is developing fully-human anti-thymocyte immunoglobulin (hIgG) for delaying the onset or progression of type 1 diabetes (T1D)
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$361.32MKey Investors
RA Capital ManagementU.S. Department of DefenseSouth Dakota Equity Partners
2025-07-21Post Ipo Equity· $175M
2023-10-02Post Ipo Equity· $130M
2023-01-18Grant· $8M
Leadership Team
Samuel Reich
Chairman & CEO
Lucy To
Chief Financial Officer
Recent News
2026-01-08
2026-01-07
2026-01-06
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