At our client's CRO we are united in our mission to accelerate the discovery, development, and production of new drug therapies, ensuring they reach those in need more swiftly. Regardless of your role, each of us plays a vital part, making a substantial impact on the health and well-being of individuals worldwide. We strive to cultivate a passionate, collaborative work environment. We are actively seeking talented, enthusiastic individuals like you to join our expanding team! Whether you are a recent college graduate or an experienced professional seeking your next career opportunity, it's time to explore your future with us. Together, We Are Altasciences.
Position: Study Director, Research Scientist
Job Description:
The Study Director, Research Scientist will demonstrate a deep passion for preclinical research. As the key point of control for assigned studies, the Study Director is responsible for the interpretation, analysis, documentation, and reporting of study results for GLP and non-GLP studies.
Responsibilities:
- Oversee the technical conduct of the study and ensure compliance with GLPs and other regulations
- Collaborate with sponsors and other stakeholders during protocol development to optimize study design
- Coordinate study logistics with clients, sub-contractors, and internal departments
- Ensure study personnel have the necessary training and education
- Prepare and obtain approval for the study protocol
- Monitor and communicate study milestones
- Record and verify all experimental data accurately
- Analyze and interpret study data, and prepare study reports
- Inform sponsors of study activities and results, and any required corrective actions
- Transfer all study documentation to the archives at the close of the study
- Review, revise, and write SOPs as necessary
Requirements:
- Masters or Doctoral Degree in a relevant scientific discipline; a Baccalaureate degree with relevant experience may be considered
- Three years’ experience as a Study Director for in vivo studies (including GLP) in a biopharmaceutical company or Contract Research Organization (CRO); one to two years’ experience in Toxicology preferred
- Intermediate to Advanced Computer Skills
- Effective communication of scientific data interpretation and conclusions
- Proficiency in mathematical and statistical methods for analysis of scientific study data
- Ability to multitask and maintain organization in a fast-paced, changing environment
- Strong planning and organizational skills
- Ability to work effectively in a team under significant time pressure
- Attention to detail and consistent ability to operate with accuracy and quality
- Proven presentation and facilitation skills
- Completion of Study Director Training, training on applicable procedures, and SOPs
- Continuing scientific and/or professional education in areas of scientific and regulatory expertise
