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.
Duties and Responsibilities (Responsibilities include but are not limited to):Study Planning and Execution:
- 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
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 with oversight of activities
- Review invoices and track 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, 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
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 ZonesPhysical 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.
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 identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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