Manager, Clinical Operations

iota Biosciences, Inc. powered by Astellas

Manager of Clinical Operations overseeing clinical projects for implantable medical devices at iota Biosciences. Leading a skilled team to ensure compliance and drive product development.

Posted 7/28/2026full-timeAlameda • California • 🇺🇸 United StatesSeniorLead💰 $145,000 - $200,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in managing clinical operations teams and executing clinical studies in compliance with Good Clinical Practices and applicable regulations. Proven ability to oversee clinical trial activities, vendor management, and cross-functional collaboration to achieve clinical and commercial goals.

Highest-signal resume keywords

Clinical Operations ManagementClinical Trial ActivitiesGood Clinical Practice (GCP)Medical Device Clinical StudiesTeam Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchClinical Execution PlansSite ManagementVendor OversightBudget ManagementGap AnalysisStudy ReportsRegulatory ComplianceData MonitoringClinical Protocol Development

Soft Skills

Effective CommunicationOrganizational SkillsSelf-MotivationAttention to DetailTeam Collaboration

Industry Keywords

Clinical Research Organizations (CROs)Class III Medical DevicesGlobal Clinical StudiesUS RegulationsKOL Relationships

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Manage a high performing clinical operations team by providing direction, subject matter expertise, training and mentorship.
Responsible for managing the design, development, modification, and evaluation of clinical execution plans (e.g., protocol, case report forms, consent forms, source document worksheets, budget, timelines, gap analysis, etc.)
Accountable for the comprehensive clinical trial activities including but not limited to study start-up, site activation, site management, vendor oversight, study reports, site and study close-out.
Provide technical direction to clinical research organizations (CROs) and oversee vendor selection/management as needed to execute clinical studies.
Work closely with hospitals and investigators participating in clinical studies and maintain close working relationships with KOLs, other investigating physicians and site coordinators.
Provide input and support for post-clinical activities and market launch of products.
Establish / support cross-functional teams to ensure optimal alignment of Clinical, Regulatory, commercial goals, site operations, data monitoring and review, and safety surveillance and reporting expectations.
Ensure clinical research programs are conducted in accordance with company standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulations.

Requirements

What you’ll need

Bachelor’s degree in a scientific field
Minimum 8+ years of relevant clinical research experience in the medical device field, or an advanced degree with a minimum of 5 years of relevant experience in the medical device field
At least 2 years monitoring experience
Experience with Class III medical device clinical studies
Proven success building and managing clinical operations teams
Comprehensive knowledge of clinical operations including Good Clinical Practices and all applicable US regulations
Experience with global clinical studies (e.g., EU or APAC regions)
Effective verbal and written communication skills
Organized, self-motivated, ability to effectively manage multiple projects and priorities; high attention to detail
Must be a strong team player and effectively interface with other departments including translational medicine, regulatory, quality, product development.

Benefits

Comp & perks

Comprehensive health coverage for you and your family, covered at 100%
Access to quality dental and vision coverage
Onsite Gym in Alameda
Generous vacation pay
Paid parental leave
Options for flexible work schedules
Annual Bonus Plan
Long Term Incentive Plan (LTIP)
401(k) plan with employer match