Description: As a Clinical Trial Manager for Diassess Inc., you will be an integral part of the team conducting clinical trials to support diagnostic product development, regulatory submissions, and commercialization. You will lead and participate in the execution of all aspects of multi-site clinical research studies. You will collaborate with people throughout the company (R&D, manufacturing, quality, regulatory, business development) as well as external vendors like CROs and consultants.
About Us: Diassess is a startup striving to transform the way infectious diseases are diagnosed. We are developing a disposable home-use test which yields results within 30 minutes. This technology bypasses centralized medical lab testing and streamlines patient care. Our current areas of focus include respiratory diseases and women’s health.
Our Vision:Healthcare costs are 18% of USA GDP, 30 million Americans are uninsured, and in some regions of the world, healthcare is nonexistent. Our company is addressing these problems by making medical diagnostics more affordable and more accessible. Ideal candidates will share our vision and passion for improving healthcare in the U.S. and around the world.
Primary Job Function
Study planning: responsible for devising study strategy and coordinating startup activities, including drafting protocols, study manuals, monitoring plans, and other study documents and templates, creating CRFs and setting up the EDC, site feasibility and selection, obtaining IRB approval, and developing and leading training of clinical research staff.
Manage studies in compliance with internal SOPs, GCP, and relevant regulations.
Serve as the point of contact for all study-related questions and issues.
Oversee and participate in monitoring activities by providing day-to-day support and conducting site visits.
Create and manage timelines and budgets to achieve study objectives.
Participate in the identification and selection of, and maintain relationships with, external resources (CROs, consultants, clinical sites).
Establish TMF and maintain accurate and up-to-date files.
Ensure data accuracy and completeness.
Coordinate study closeout activities including clinical study reports, TMF audit and archiving, database lock and archiving, and site closeout visits.
Coordinate with manufacturing and vendors to facilitate shipping of study supplies and ensure accountability records are maintained.
Education, Experience, and Training
Bachelor’s degree with 3 years in clinical research and 1+ years related experience leading multi-site clinical research studies
The ideal candidate would possess many of the following skills and would be excited to learn the rest:
Extensive knowledge of FDA guidelines and global regulation of medical devices, relevant regulations such as 21 CFR parts 50, 54 and 56, and Good Clinical Practice (GCP)
Experience with leading cross-functional teams in executing clinical projects
Strong writing and analytical skills
Experience with establishing and/or working with a quality management system (QMS)
Excellent communication skills, and the ability to interface with clinicians, scientists, engineers, and regulatory agents
Strong attention to detail, work ethic, time management skills, and the ability to multi-task
Ability to work both independently and collaboratively to find creative and resourceful solutions to problems
Project management training and/or experience in project management
Competitive salaries and meaningful equity
Unlimited PTO and flexible hours for work/life balance
Health, vision, and dental insurance w/ FSA
Life and long-term disability insurance
401(k) retirement savings plan
Choice of gym membership or commuter benefits
Weekly group lunch and a fully stocked snack kitchen
Your choice of professional equipment and software
Relaxed and collaborative culture
One block from Emeryville BART shuttle stop
Many cafes, bars, and restaurants within 5 min walk
Diassess is an Equal Opportunity Employer.
Individuals seeking employment at Diassess are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation