iota Biosciences, Inc. powered by Astellas · 1 month ago
Clinical Operations Manager
400 Wind River Way Alameda, CA 94501
Full-time
Onsite
Mid, Senior Level
$105K/yr - $130K/yr
3+ years expiota Biosciences, a subsidiary of Astellas Pharma US, is focused on advancing bioelectronic medicines through the development of implantable medical devices. The Clinical Operations Manager will lead the operational execution of early clinical research, coordinating research collaborations and ensuring compliant execution of studies.
BiotechnologyLife ScienceMedical
Responsibilities
Lead operational planning and execution for ongoing and upcoming non-significant risk and exploratory human research studies, ensuring studies launch and run efficiently
Coordinate with clinical investigators, institutional partners, and internal teams to manage timelines, documentation, and communication
Prepare and submit IRB applications, amendments, and renewals; draft and maintain informed consent forms, recruitment materials, and other study documents
Support development and maintenance of electronic data capture (EDC) systems and oversee accurate, timely data entry and quality control
Manage safety event and deviation reporting processes, ensuring compliance with internal procedures, IRB requirements, and applicable regulations
Contribute to the development and refinement of study protocols, manuals, and case report forms, focusing on operational clarity and compliance
Track study milestones, enrollment progress, and deliverables across multiple concurrent studies, maintaining organized and audit-ready documentation
Plan and facilitate cross-functional meetings, summarizing key actions and ensuring timely follow-up across stakeholders
Develop and implement scalable study management processes and templates to support the transition from exploratory research to early feasibility and pivotal studies
Support and coordinate institutional research collaborations, including studies involving external hospitals, academic centers, and research units
Qualification
Required
Bachelor's degree in public health, neuroscience, bioengineering, nursing, or a related field
3+ years of experience in clinical research operations, study coordination, or clinical trial coordination in medical device manufacturer-sponsored studies
3+ years of experience in clinical operations in medical device studies
Strong understanding of IRB processes, human subjects research ethics, and study documentation
Familiarity with Good Clinical Practice (GCP) guidelines, ISO 14155, and FDA IDE processes
Strong organizational instincts, project management skills, and excellent attention to detail
Ability to communicate effectively across technical and non-technical stakeholders
Proven ability to manage multiple priorities independently in a fast-paced, multidisciplinary environment
Preferred
Master's degree (MPH, MS, or equivalent) in a relevant field
3+ years of experience independently managing clinical studies or related projects
Experience with medical device or early-phase human research studies
Familiarity with academic or hospital-based collaborations
Working knowledge of FDA NSR and early feasibility study frameworks
Experience establishing and managing study systems (EDC, document management, etc.) in a startup or small-company setting
Experience establishing clinical research infrastructure or SOPs in a startup or small-company setting
Company
iota Biosciences, Inc. powered by Astellas
iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company working to develop pioneering bioelectronics to advance the treatment and management of disease.
51-200 employees
H1B Sponsorship
iota Biosciences, Inc. powered by Astellas has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (15)
2023 (6)
2022 (11)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$15M2020-10-15Acquired
2018-12-27Series A· $15M
Leadership Team
Michel Maharbiz
Chief Executive Officer
Recent News
Google Patent
2025-05-05
Google Patent
2025-05-05
2025-05-05
Company data provided by crunchbase