For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. Job Summary
We are seeking a Research Scientist 1, Program Management
for our Safety Assessment
site located in Shrewsbury, MA
Serve as a scientist and laboratory study manager driving the conduct of assigned clinical and non-clinical studies of basic to moderate complexity, to include study and timeline management, preparation, phase planning, coordination with technical teams, execution of laboratory analyses, reporting of study data, and ensuring the appropriate regulatory compliance of these projects.ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Serve as a Principal Investigator/Individual Scientist/Project Scientist in the direction and execution of assigned studies in compliance with GLP regulations as they apply to the conduct of clinical and nonclinical research.
- Participate in and coordinate all phases of the study planning process with appropriate departments.
- Generate Phase Plans, Laboratory Methods, and reports appropriate for assigned studies.
- Review, integrate, and present data on assigned studies, using the assistance of scientific staff as appropriate.
- Function as the primary contact for the planning and execution of sponsor interaction related to assigned studies, including proposal management and study scheduling, conduct and reporting.
- Perform data management for clinical studies, including drafting, reviewing and executing Data Transfer Agreements, data reconciliation and generation/delivery of data transfers.
- Work closely with Scientific Coordinators to address clinical program management activities.
- Provide technical and scientific guidance to the research staff.
- Attend scientific meetings, conferences and training courses to enhance job and professional skills.
- Perform all other related duties as assigned.
The following are the minimum qualifications
required for the Research Scientist 1, Program Management
About Safety Assessment
- Education: Bachelor's degree (B.S./B.A.) or equivalent in a scientific related discipline. Related Master's degree (M.S./M.A.) or PhD/DVM preferred.
- Experience: Minimum of 6 to 7 years related experience in the contract research, academic, or pharmaceutical industry.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: None.
- Other: Understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate. Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft® Excel, Word, Powerpoint, etc. and with standard laboratory calculations.
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.