Clinical Project Manager
At SAB Biotherapeutics (SAB), we are using the sophistication of science and genius of nature to change the landscape of human health. Our team of scientists, researchers and professionals has made it their life's work–with technology and tenacity–to pioneer a new powerful platform to make an impact that is global + personal. Through advanced genetic engineering and antibody science, we are dedicated to advancing a new class of immunotherapies, leveraging the native human immune response, with first-in-class and best-in-class potential across broad therapeutic categories including autoimmune, inflammation, infectious disease, and immune-oncology. SAB-185, is among the elite therapy candidates for COVID-19, advancing with Operation Warp Speed. As true innovation, our novel platform is also being developed in a rapid response capacity for future pandemic response.
The Clinical Project Manager will be responsible for management and oversight of the day-to-day operations of clinical trials and studies. This position will ensure all work is conducted in accordance with SOPs, policies, good clinical practices, and applicable regulatory requirements. This position will be responsible for ensuring clinical trials and studies meets quality and timeline metrics. This position requires familiarity and understanding of drug product and clinical trial life cycle. This position also requires knowledge in biological sciences, strong organizational, management, interpersonal skills, and familiarity with a variety of the field’s concepts, practices, and procedures.
Essential Duties and Responsibilities:
• Oversees Clinical Project Manager task assignments and ensures prompt completion of tasks
• Manage deliverables, track and ensure timely reporting
• Initiates, completes, and reviews study specific documents
• Monitor’s study activity and works as a liaison between the sponsor and CROs to track progress and completion of studies
• Works with CROs to coordinate and manage sample logistics and testing
• Works with the document management team as appropriate to transfer documents in a timely manner
• Performs other duties and responsibilities as assigned.
This position does not supervise employees.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education, Experience and Certifications:
Requires a bachelor’s degree in biology or other relevant fields with 1-2 years of experience in program management, clinical trial coordination, and/or biopharmaceutical preferred. Understanding of pharmaceutical industry activities and development processes also preferred.
Must have strong oral and written communication skills. The ability to write in-depth proposals and technical reports that require knowledge in the biological sciences, clinical trial and drug product life cycle, and detail project structure, procedures, and outcomes is critical. Must be proficient in Microsoft Office software (Word, Excel, PowerPoint, Project, and Outlook). Ability to effectively present information in one-on-one and group settings.
Utilize established mathematical and scientific techniques to compile and analyze data.
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 long periods at any given time. The employee must occasionally lift and/or move up to 10 pounds.
Normal office working conditions.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.