Clinical Trial Manager, Immunology

Duties and Responsibilities

• Lead the design and implementation of clinical trial protocols, including site selection, patient recruitment strategies, and timeline development
• Contribute to the development of study protocols, protocol amendments, study manuals, ICFs, CRFs, Investigator Brochures (IBs) and other study-related documents as required
• 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

Requirements

• 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
• 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
• Experience with operational financial tracking systems a plus
• Experience using various EDC, CTMS and eTMF (Veeva, Agatha) systems
• Experience using MS Office applications, including MS Word, Excel, PowerPoint
• Experience using Smartsheet
• Able to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials
• Excellent written and verbal communication skills

Working Environment and Travel

• Generally accepted office working conditions
• Travel up to 25% - ability to travel domestically and internationally
• Prefer candidates located in Central or Eastern Time Zones

Physical Requirements

• While performing the duties of this job, the employee is regularly required to walk, stand and sit.
• The employee will be able to use a computer for extended periods at any given time.
• The employee must regularly lift and/or move up to 10 pounds.

ADA

• The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

EEO/AA/Vets

• SAB Bio is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.
• SAB Bio is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.

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