Clinical Trial Manager, Immunology

SAB BIO; Miami Beach (FL); On-site; USD 120,000 - 150,000; Full time

Job summary

SAB Bio is seeking a Clinical Trial Manager to plan, implement, and oversee multiple clinical trials. You will lead cross-functional teams, manage site relationships, and ensure budgets and timelines are met while maintaining high data quality and regulatory compliance.

Responsibilities include protocol development support, trial master file readiness, vendor management, and regular stakeholder communications. Travel up to 25% is expected; remote work not emphasized.

Qualifications

• B.S. degree with 6-8+ years' clinical trial management experience in biotech/pharma.
• Global trial and CRO management experience.
• Experience with phase II/III study oversight.
• Strong leadership, decision-making and problem-solving skills.
• Proficient in GCP, FDA/EMA/MHRA regulations.
• Experience with EDC, CTMS, and eTMF systems (Veeva, Agatha) and financial tracking.
• Proficient MS Office; Smartsheet experience.
• Excellent written and verbal communication.
• Ability to work with minimal supervision and multi-task.

Responsibilities

• Lead design and execution of trial protocols, site selection, recruitment strategies, and timelines.
• Oversee study documents: ICFs, CRFs, IBs; maintain Trial Master File for inspections.
• Manage trial budgets, timelines, and regulatory compliance across trials.
• Coordinate with CROs and external vendors; track invoices and forecasts.
• Collaborate with cross-functional teams (CRAs, data managers, regulatory) to ensure trial success.
• Establish and maintain relationships with trial sites and ensure protocol compliance.
• Monitor data integrity and adherence to GCP; identify and mitigate trial risks.
• Prepare updates for stakeholders and run regular progress meetings.

Skills

Leadership

Project management

GCP knowledge

Regulatory affairs

Budgeting

Communication

Problem solving

Multi-tasking

Education

B.S. degree

Tools

Veeva CTMS

Agatha

eTMF system

MS Office

Smartsheet

Job description

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.

Responsibilities

• Study Planning and Execution:
  • 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 the implementation and maintenance of the Trial Master File for inspection readiness.
• Project Management:
  • 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 and oversee their activities.
  • Review invoices and track the study budget according to the forecast, working closely with finance and clinical business operations.
• Team Leadership:
  • Collaborate with cross‑functional teams, including clinical research associates, data managers, and regulatory affairs, to ensure successful trial execution.
• Site Management:
  • Establish and maintain strong relationships with clinical trial sites. Provide ongoing support and oversight to ensure compliance with protocol and regulatory standards.
• Data Integrity and Compliance:
  • Monitor trial progress, ensuring accurate data collection, timely reporting, and adherence to Good Clinical Practice (GCP) guidelines.
• Risk Management:
  • Identify potential study risks and develop mitigation strategies to ensure successful trial outcomes.
• Communication:
  • 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 or pharmaceutical settings.
• Strong clinical study conduct experience from start‑up through close‑out, with global trial and CRO management experience.
• Experience with phase II and 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 is a plus.
• Demonstrated proficiency using MS Office applications, including Word, Excel, and 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.

Working Environment and Travel

Generally accepted office working conditions. Travel up to 25% – ability to travel domestically and internationally. Preference for 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 Statement

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.