Clinical Operations Manager

About Us

iota Biosciences, a wholly owned subsidiary of Astellas Pharma US, is advancing a new class of bioelectronic medicines through the development of fully implantable Class III medical devices. Our proprietary technologies open therapeutic and diagnostic possibilities not previously accessible to clinicians.

Together with Astellas, we are committed to patient-centric design, scientific and engineering excellence, and cross-functional teamwork. These principles guide us in bringing transformative, first-of-its-kind technologies into the clinic and closer to patients.

Job Summary

We are seeking a Clinical Operations Manager to lead the operational execution of our early clinical research portfolio. This individual will be responsible for coordinating institutional research collaborations, supporting IRB and study documentation, and ensuring smooth and compliant execution of exploratory and early feasibility studies. This role is ideal for someone who thrives in a dynamic, multidisciplinary environment and wants to grow into program-level clinical leadership as our human research activities expand.

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.

Key Qualifications

• 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 Qualifications

• 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.

Job Type

• Hybrid, based out of our Alameda, CA location (open to remote)

• Up to 30% travel