Your New Company!
CRO looking for a Study Director. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future. We are better together and together.
About The Role
The Study Director will be representing the single point of control for a study. They are responsible for the interpretation, analysis, documentation, and reporting of study results.
What You'll Do Here
- Performs functions of a Study Director with a full SD workload, including GLP studies.
- Functions as an independent Study Director with overall responsibility for the technical conduct of assigned studies.
- Performs functions in accordance with GLPs and other applicable regulations and/or guidance as they apply to the conduct of nonclinical studies.
- Consults with Sponsors, contributing scientists, and other key individuals during Protocol development to optimize Protocol design and appropriately outline study objectives.
- Coordinates all phases of a nonclinical study in collaboration with internal departments, external vendors, and clients.
- Confirms with management that study personnel have the training and education to perform their assigned function(s).
- Ensures that current copies of approved Protocol and Amendments/Amended Protocols are available to all study personnel and Sponsors.
- Prepares the Project Review Form and obtains approval of the study by the IACUC. Plans and hosts client visits.
- Monitors, tracks, and communicates study milestones effectively to all contributors (internal and external), including the Sponsor.
- Assures that all experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified.
- May represent the company at professional meetings.
- Observes procedures involving biological or chemical hazards
- Develop and reviews SOPs, as necessary.
What You'll Need To Succeed
- Masters, doctoral or equivalent degree in a relevant scientific discipline. A Bachelor or equivalent degree and relevant experience may substitute for the education requirements for this position.
- Minimum three years in a scientific capacity in biomedical research in an academic, industrial, or Contract Research Organization (CRO) environment.
- Intermediate to advanced computer skills
- Verbal and written communication skills in English; the ability to read, analyze, understand, discuss and interpret complex scientific and regulatory documents.
- Ability to effectively communicate scientific data interpretation and conclusions.
- Ability to utilize and interpret appropriate mathematical and statistical methods for analysis of scientific study data.
- Continual GLP training. Must complete New Study Director Training, training on applicable procedures and SOPs.
- Continuing scientific and/or professional education in areas of scientific and regulatory expertise. Continuing Study Director Training.
- Ability to multi-task and maintain organization in a fast paced, rapidly changing environment. Ability to manage change. Demonstrated expertise in a scientific discipline.
- Strong planning and organizational skills.
- Ability to work effectively and cooperatively in a team environment under significant time pressure.
- Demonstrated attention to detail and consistent ability to operate with accuracy and quality.
- Proven presentation and facilitation skills.
- Ability to successfully operate independently with minimal guidance.
- Medical, scientific or technical writing skills
