Clinical Operations Manager - Immunology/Neurology
Location: Boston, MA
Travel Required: Up to 25%
Akili is looking for a full-time Clinical Operations Manager to join our growing Clinical Operations team in Boston, Massachusetts. The Clinical Operations Manager role will oversee and manage multiple multi-site clinical trials of Akili’s digital medicine products from start-up to close-out.
Specific duties include:
- 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
- Up to 25% travel to clinical sites
- 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
- 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.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Akili is an equal opportunity employer that embraces diversity and inclusion.
To apply for this position, contact us through Puretech Health.