Study Director - Americas CRO

Argenta•Oakland, NE

3d•Onsite

About The Position

Argenta is seeking a Study Director for their Oakland, NE location. This role is crucial in overseeing animal health product development studies, ensuring compliance with regulatory requirements and Good Laboratory Practices (GLP). The Study Director will manage studies from protocol approval to final report signing, coordinating with sponsors, quality assurance, and internal teams. This position requires a strong scientific background, extensive experience in animal health product development or clinical study management, and the ability to lead and motivate cross-functional teams. Argenta is a global leader in animal health, offering a unique CRO/CDMO service, and is committed to a 'one team' culture focused on innovation, customer-centricity, and improving animal lives.

Requirements

Advanced degree in a scientific discipline
10+ years experience in animal health product development, or veterinary clinical study project management
Proven experience managing cross functional teams
Thorough knowledge of practical experience in GLP protocols, Final Study Reports and Study Master Files
Collaborative working style and the ability to lead and motivate people at all levels and across multiple functions within the organization
Proven affinity with Animal Health
Excellent attention to detail and scientific judgement

Responsibilities

Approve and sign study protocol
Ensure objectives meet regulatory requirements
Coordinate with Sponsors and Quality Assurance
Delegate tasks accordingly during the course of the study but retain full responsibility
Ensure the study follows GLP and study protocol, overseeing animal care, sample collection and data recording
Address deviations and ensure proper documentation
Review and interpret results ensuring the scientific validity of conclusions
Write, approve and sign the final study report
Ensure all raw data are archived properly