Penumbra, Inc. · 1 month ago
Clinical Study Manager
United States
Full-time
Remote
Senior Level
$123K/yr - $170K/yr
5+ years expPenumbra, Inc. is a global healthcare company focused on innovative therapies, and they are seeking a Clinical Study Manager to lead the planning, design, and execution of clinical studies. This role involves managing study-related documents, coordinating with various stakeholders, and ensuring compliance with regulatory requirements.
BiotechnologySoftwareMedical DeviceDeveloper Platform
Responsibilities
Develops/maintains project timeline inclusive of startup through completion (e.g., database build, data snapshots for study reports, abstracts, manuscripts, DSMB, CEC meetings, and regulatory submissions)
Drives development, approval, and distribution of study-related documents and study tools for investigational sites and review committees as directed by management
Manages distribution, collection and tracking of regulatory documentation to help ensure audit readiness at both the sites and Penumbra headquarters
Negotiates study budgets with sites, Core Labs, and other vendors
Attends site visits as necessary (e.g., site initiation, monitoring, and close out visits)
Contributes to process improvements that help foster continuous improvement
Helps update and maintain study trackers and dashboards
Participates in system user acceptance testing
Manages vendors such as Core Lab
Organizes and manages Investigator Meetings
Works with data management to develop systems for and track project metrics
Drives development, approval, and distribution of study-related documents including Case Report Forms, study manuals
Leads activities for internal and regulatory audits
Monitor progress of studies, identify study-related trends/issues and with the clinical team, implements corrective actions when necessary
Coordinates activities associated with study start-up and management. Provides solutions to challenges such as enrollment in the clinical study
Represents the Clinical Affairs Department on cross-functional meetings and projects as needed
Works with and communicates effectively with cross functional teams including Regulatory Affairs, Marketing, Legal, Customer Service, R&D, Finance, and Sales
Attends scientific conferences and interacts with key opinion leaders. Maintains proactive communication regarding all study related activities with study PIs
Assists management with regulatory submissions and other clinical study reports
Supports the study team by answering protocol-specific questions (assist in resolution of patient eligibility questions and protocol deviations)
Mentors and trains staff regarding protocols, good clinical practice, departmental processes, etc
Assists team members in managing challenging investigators/staff
Assists in selection of vendors, such as Core Labs
Travels as needed to meet project milestones
Leads moderately complex multidisciplinary (stats, DM, clinical) US and OUS clinical projects
Evaluates, analyzes, and interprets data and presents in a clear, well organized, scientifically sound report
Drafts Investigator Meeting content
Forecasts study timelines and budgets
Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company
Ensure other members of the department follow the QMS, regulations, standards, and procedures
Perform other work-related duties as assigned
Qualification
Required
Bachelor's degree in Biological Sciences or related field with 5+ years of experience, or equivalent combination of education and experience
5+ years of relevant clinical trial experience required (clinical/scientific research, nursing, or medical devices/pharmaceutical industry)
Must be familiar with laws, regulations, standards, and guidance governing the conduct of clinical studies including knowledge of CFR and GCP/ICH requirements
Proficiency with Microsoft Office, MS Project, EDC Systems, study management systems, and vendor oversight
Excellent oral, written, and interpersonal communication skills with fluency in English and local language, if different is required
Ability to solve problems creatively with keen attention to details; ability to work on teams on multiple projects simultaneously
Working knowledge of medical terminology required
High degree of accuracy and attention to detail
Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously
Preferred
Field experience preferred
Benefits
A benefits and equity program, when applicable
Medical, dental, vision, life, AD&D, short and long-term disability insurance
401(k) with employer match
Paid parental leave
Eleven paid company holidays per year
A minimum of fifteen days of accrued vacation per year, which increases with tenure
Paid sick time in compliance with applicable law(s)
Company
Penumbra, Inc.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies.
1001-5000 employees
H1B Sponsorship
Penumbra, Inc. 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
8%
Represents job field similar to this job
Management and Executive
Engineering and Development
Legal and Compliance
Accounting and Finance
Marketing
Sales
Customer Service and Support
Trends of Total Sponsorships
*2026 (24)
2025 (35)
2024 (40)
2023 (45)
2022 (43)
2021 (36)
2020 (26)
Funding
Current Stage
Public CompanyTotal Funding
$2.87M2026-01-15Acquired
2021-08-23Post Ipo Equity· $2.75M
2015-09-18IPO
Leadership Team
Adam Elsesser
CEO
Shruthi Narayan
President
Recent News
2026-06-19
Company data provided by crunchbase