Clinical Operations Manager - Immunology/Neurology
Akili is looking for a full-time Clinical Operations Manager to join our growing Clinical Operations team in Boston. You will oversee and manage multiple multi-site clinical trials of Akili’s digital medicine products from start-up to close-out.
Here's what it entails
- You will contract, budget, timeline, milestone and deliverable oversight for multiple multi-site trials
- Preparation of clinical study documents for IRB submission including Protocol and ICFs
- EDC development and monitoring
- On-site training (Protocol and Study Device)
- Planning and/or conducting site qualification and initiation visits and Investigator Meetings
- Coordinating external vendor/CRO/ and site relationship management
- Daily interaction with CRO and study site personnel
- Compliance with applicable GCP guidelines
- Cross-functional interaction to identify and evaluate fundamental project issues
- Travel up to 25% travel to clinical sites
Here's what you need
- Bachelor’s or Master’s degree in a scientific or health-care related discipline
- 3-5 years’ experience in Clinical Operations overseeing and conducting clinical research studies in a pharmaceutical, biotech or medical device company with at least 2 years as Project or Operations Manager
- Tech-savvy with an ability to embrace mobile app-based software as a medical device
- Excellent communication and presentation skills
- Strong problem solving skills and comfort with multi-taking in a fast-paced environment.
- Flexibility to adapt to quickly to evolving goals and responsibilities
- Preference for experience in Immunology/Neurology or behavioral/psychiatric studies
- Outstanding individual performer and team player.
Akili - The company
Akili Interactive (www.akiliinteractive.com) is creating an entirely new class of medicine that combines rigorous scientific validation with engaging video game mechanics.
We are pioneering the field of digital therapeutics, creating, producing, and validating digital medicines designed to directly treat disease. Akili's flagship product, Project: EVO, is based on technology developed at UCSF that was featured as the cover article in Nature under the headline "Game Changer".
Akili was founded by leading neuroscientists and top-tier game design veterans to create gaming experiences that are designed to have measurable health impacts in multiple patient populations. Akili has partnerships with top pharmaceutical companies, and has received recent recognition in major media outlets including the Wall Street Journal, CNBC, Fast Company, and The Verge.