Study Director (NAMSA Talent Building Community)

Job Description

Affords assistance in coordinating study conduct tasks from initiation to completion. Performs non-complex studies and serves as the primary client contact, keeping them updated on schedules and unforeseen events or issues. Ensures compliance with applicable quality system regulations (ISO, GMP, GLP) and NAMSA Standard Operating Procedures (SOPs). Understands and adheres to animal welfare requirements and acts as Principal Investigator when necessary. Oversees GLP and non-GLP preclinical studies, ensuring adherence to GLP regulations. May participate in study-specific procedures. Analyzes and interprets data, presenting clear, well-organized reports. Ensures accurate recording, verification, and organization of data, especially for GLP studies. May archive study records upon completion. Interacts with regulatory bodies, prepares protocol submissions for IACUC review, and addresses committee comments. Engages in client discussions about study design when needed. Develops and leads moderately complex study designs, serving as the primary contact for the client and informing them of schedules and issues. Manages internal teams to meet client expectations. Understands investigational products, evaluates, analyzes, and interprets study data, and presents findings in a clear, well-organized manner. Assists with departmental training as needed. Performs other duties as assigned.

Qualifications & Technical Competencies

• Requires a minimum of a Bachelor’s degree, preferably in a scientific discipline, with at least two years of related laboratory experience.
• Master’s degree/PhD with at least one year of relevant laboratory experience preferred.

Working Conditions

• Exposure to general office conditions and personal computers/keyboard use.
• Exposure to a variety of livestock, domestic and laboratory animals, fluoroscopy, faxitron x-ray imaging, sharp objects, radioactive isotopes, toxic or caustic chemicals, and BSL2 environments.
• Rare exposure to zoonotic diseases and bloodborne pathogens.
• Sit, stand, walk, use hands and fingers, reach with hands and arms, talk, hear, use computer keyboard, and view computer monitors.
• Lift and/or move up to 50 pounds occasionally.
• Specific vision abilities required include close vision, the ability to adjust focus, exceptional spatial acuity, and visual-kinesthetic coordination.

Vision to Inspire Innovative MedTech Solutions

To advance global healthcare, improve patient lives, and accelerate client success.

Mission to Deliver Best-in-Class Global MedTech Development Solutions

Through our people, expertise, and technology, while adhering to our core values of acting with integrity, providing best-in-class customer experiences, developing superior talent, delivering timely results, embracing collaboration, diverse perspectives, and ideas.