The Preclinical Study Manager will serve as a Subject Matter Expert (SME) and Project Manager in the coordination of R&D Preclinical Research including but not limited to: in-vivo study design (Safety and Efficacy/Functionality evaluations), Preclinical Research Management, Vendor Management, and Preclinical Regulatory Strategy.
POSITION DUTIES & RESPONSIBILITIES:
The Preclinical Study Manager will play an important role in the client's Orthopedic organization supporting R&D product development. The main focus will be to provide scientific expertise in the design and conduct of preclinical research related to orthopaedic medical device product development. The role requires close collaboration with internal and external customers, strong project management skills, and direct experience working in a GLP environment. The position will also be responsible for oversight of preclinical research conducted at external sites.
Be a Subject Matter Expert (SME) for preclinical research
Work with Contract Research Organizations (CROs) or Academic Institutions to outsource Safety and Efficacy/Functionality preclinical in-vivo research
Plan, direct, and coordinate activities related to the design, initiation and follow-up of studies to support approval of Class I-III medical devices
Expert knowledge of scientific principles and analytical problem solving skills
Demonstrate technical proficiency, scientific creativity, and independent thought
Conduct critical analysis of data and results and recommend paths forward based on analysis
Maintain documentation according to GLP and Quality System requirements
Develop study protocols and be able to clearly document, analyze, interpret, and report results
Regularly interface with team members to ensure research reflects strategy and goals
Able to effectively communicate data and results to team members and other company personnel
Knowledge of animal and human anatomy and physiology, as well as biological systems
Understand, elaborate, and consider regulatory issues in decision making
Knowledge of regulations regarding medical device development and the utilization of live animals
Able to handle multiple tasks and responsibilities
EDUCATION & EXPERIENCE REQUIREMENTS:
A minimum of a Master's Degree in Biological Science, Biomedical Engineering, Veterinary Medicine or a related discipline is required.
Minimum 5 years' experience in preclinical medical device research
Strong understanding of ISO 10993, Good Laboratory Practices, FDA and international regulatory frameworks, and latest industry trends is required
Scientific knowledge of experimental preclinical study design, preclinical data analysis and data interpretation
Negotiate, draft, and manage research contracts and agreements with pre-clinical sites
Manage budgetary issues for all in-vivo research projects to support efficacy and safety programs
Knowledge of surgery, anatomy, toxicology, and pathology
Experience with large animal in vivo surgical research and CRO vendor management
Orthopedic medical device product development and research experience preferred
Excellent computer, communication, and written skills are required. Proficient in Microsoft WORD, Excel, PowerPoint
Familiarity with basic orthopaedic tools and techniques
Excellent organizational, time management, and documentation management skills