Clinical Trial Manager - Immunology

Role Overview

The Clinical Trial Manager is responsible for spearheading the design, implementation, and oversight of clinical trials to ensure efficiency, regulatory compliance, and ethical conduct throughout the study lifecycle. This role requires coordination across multiple functional areas, management of timelines and budgets, and upholding high-quality standards to guarantee successful trial completion.

Key Responsibilities

• Lead development and execution of clinical trial protocols, focusing on site selection, patient recruitment, and timeline setting.
• Contribute to drafting and amending study protocols, manuals, informed consent forms, case report forms, investigator brochures, and additional trial documents.
• Ensure proper implementation and maintenance of the Trial Master File to meet inspection standards.
• Oversee all clinical trial operations including adherence to deadlines, financial constraints, and regulatory requirements.
• Collaborate with Clinical Research Organizations to identify, assess, select, and manage trial sites.
• Supervise external vendors and monitor their activities to ensure compliance and deliverables.
• Manage study budgets by reviewing invoices and tracking financial forecasts in conjunction with finance and clinical business teams.
• Work closely with cross-functional groups such as clinical research associates, data managers, and regulatory affairs specialists to facilitate trial progress.
• Maintain strong partnerships with clinical trial sites, providing ongoing support and ensuring adherence to protocols and regulations.
• Monitor trial data integrity, timely reporting, and maintain compliance with Good Clinical Practice guidelines.
• Identify and mitigate risks throughout the trial to safeguard successful outcomes.
• Communicate study updates to internal and external stakeholders through presentations and regular meetings.

Candidate Qualifications

• Bachelor’s degree with at least 6 to 8 years of hands-on experience managing clinical trials in biotechnology or pharmaceutical industries.
• Proven expertise overseeing clinical studies from initiation through close-out, including managing global trials and CROs.
• Experience managing phase II and III clinical trials.
• Strong skills in timeline management, leadership, decision-making, and problem-solving.
• Experience with document reviews focusing on inspection readiness using appropriate systems.
• Well-versed in relevant Good Clinical Practices as well as FDA, EMA, and MHRA regulations.
• Competency in utilizing various electronic data capture (EDC), clinical trial management systems (CTMS), and electronic Trial Master File (eTMF) platforms such as Veeva and Agatha; financial tracking system experience is advantageous.
• Proficient with Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet software.
• Capable of managing multiple priorities with minimal supervision and delivering on deadlines across several trials.
• Excellent communication skills, both written and verbal.

Working Conditions and Travel

• Standard office environment.
• Travel requirements up to 25%, domestically and internationally.
• Preference for candidates located within Central or Eastern Time Zones.
• Physical demands include the ability to walk, stand, sit for long periods, use a computer extensively, and occasionally lift or move items up to 10 pounds.

Equal Opportunity Employment

SAB Bio is dedicated to creating an inclusive workplace and provides reasonable accommodations in line with the Americans with Disabilities Act of 1990. The company practices equal employment opportunities without discrimination based on race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other protected classification.