Position Summary: Actively participates on cross-functional project teams responsible for the development and commercialization of molecular diagnostic assay products. Oversees clinical studies from concept through contract completion and directly manages the day-to-day activities of clinical studies. Resolves operational issues and responds to questions related to clinical studies. Fosters cross-functional relationships to create a cooperative work environment in support of corporate goals.
- Plans, develops, and manages complex clinical study programs for IVD products.
- Manages day-to-day activities of all aspects of clinical studies for assigned projects. including study plans, timelines, resources, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams.
- Manages independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment.
- Manages the development and implementation of improved processes for execution of clinical studies within the HTG Molecular Quality System.
- Monitors work to ensure quality, and continuously promote quality and compliance to HTG’s Quality System.
- Supports molecular diagnostic assay development from late concept through clinical validation.
- Works cross functionally to bring novel molecular assays through validation, Regulatory Body approval and commercialization.
- Collaborates with external research and clinical investigators.
- BA/BS in a related field; MA/MS or Ph.D. strongly preferred 5 years of experience in a regulated, CRO, diagnostic (IVDs), and/or pharmaceutical industry with regulated documentation and/or Project Coordination/ Management.
- Experience with Quality processes.
- Project and/or Clinical trial management experience.
- Experience with Regulatory Body audits/inspection of clinical studies.
- Demonstrated experience in problem solving and providing oversight of program-related activities.
- Demonstrated experience managing time and projects to meet deadlines
- Experience with product development design control process
- Background in molecular biology/biochemistry, laboratory experience preferred
- Regulatory requirements such as FDA QSRs, ISO 13485, GCP, GLP, GMP, IDE, IRB, etc.
- Effective organizational skills with particular attention to details
- Ability to communicate effectively
- Ability to contribute novel ideas to solve problems
- Ability to independently carry out objectives
- Ability to create and track detailed project plans
- Effective time management.
Physical, Mental, and Environmental Requirements:
Weekend and evening work required in order to meet deadlines. Work is indoors in a seasonally heated and airconditioned environment. The position is sedentary and requires typing and the ability to move objects weighing up to 25 lbs. Occasional travel is required.
HTG Molecular Diagnostics, Inc. is an EEO employer - M/F/Vets/Disabled