Clinical Trial Manager, Immunology

The Clinical Trial Manager (CTM) oversees the planning, implementation and management of clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory guidelines. The CTM plays a critical role in coordinating cross‑functional teams, maintaining budgets, timelines, and quality standards, and ensuring the successful execution of clinical studies.

• 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, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Investigator Brochures (IBs) and other study‑related documents as required.
• Oversee implementation and maintenance of the 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, providing 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, and facilitate regular meetings to discuss study progress and address challenges.

• B.S. degree with minimum 6‑8+ years of experience managing clinical trials in biotech or 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.
• 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.
• 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 manage deliverables across all trials.
• Excellent written and verbal communication skills.

Generally accepted office working conditions.

Travel up to 25%—ability to travel domestically and internationally.

Prefer candidates located in Central or Eastern Time Zones.

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.

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

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. EOE/AA/Vets.