Full-Time

Clinical Study Manager

Posted on 1/25/2025

Penumbra Inc

Penumbra Inc

1,001-5,000 employees

Develops medical devices for vascular conditions

Compensation Overview

$123k - $170kAnnually

Senior

Company Historically Provides H1B Sponsorship

Remote in USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Google Cloud Platform
Requirements
  • 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
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
Desired Qualifications
  • Field experience preferred

Penumbra Inc. specializes in creating medical devices aimed at treating neurovascular and peripheral vascular conditions. Their products include a variety of devices for neuro interventions, such as the Penumbra System and the Penumbra SMART COIL, which are used to address issues like stroke. For peripheral vascular diseases, they offer the Indigo System and related devices. These products are designed to assist healthcare professionals in hospitals and clinics, primarily in Europe and the Americas. What sets Penumbra apart from competitors is their focus on continuous research and development, ensuring their devices meet the changing needs of the medical field. The company's goal is to provide effective and high-quality medical solutions that improve patient outcomes in neurovascular and peripheral vascular care.

Company Size

1,001-5,000

Company Stage

IPO

Headquarters

Alameda, California

Founded

2004

Simplify Jobs

Simplify's Take

What believers are saying

  • Growing demand for minimally invasive procedures boosts Penumbra's market potential.
  • Global neurovascular devices market is projected to grow at 8.5% CAGR until 2030.
  • Technological advancements enhance effectiveness of Penumbra's neurovascular treatments.

What critics are saying

  • Leadership gap due to Don Kassing's retirement may affect strategic decisions.
  • Costa Rica manufacturing expansion could face operational challenges and increased costs.
  • Layoffs in Immersive Healthcare division indicate potential strategic instability.

What makes Penumbra Inc unique

  • Penumbra specializes in neurovascular and peripheral vascular medical devices.
  • The company offers innovative solutions for stroke and neurovascular disease treatment.
  • Penumbra's global presence spans North America, Europe, Asia, and Australia.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Parental Leave

Paid Vacation

Paid Sick Leave

Paid Holidays

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
Neuro News International
Feb 28th, 2025
Penumbra launches Access25 delivery microcatheter designed for brain aneurysm access

Penumbra launches Access25 delivery microcatheter designed for brain aneurysm access.

Penumbrainc
Feb 27th, 2025
Penumbra Launches ACCESS25[TM] Delivery Microcatheter Designed for Aneurysm Access and Delivery of Elevated Clinical Benefits

Penumbra recently launched the ACCESS25 Delivery Microcatheter, a single lumen medical device designed to aid physicians in accessing the neurovasculature for the delivery of Penumbra's advanced .020" coil platform.

PR Newswire
Feb 21st, 2025
Penumbra, Inc. Announces Don Kassing Will Retire From Board Of Directors

ALAMEDA, Calif., Feb. 21, 2025 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), the world's leading thrombectomy company, announced today that after 17 years of distinguished service, Don Kassing has notified the company that he will retire from the board of directors effective April 1, 2025. Kassing joined Penumbra's Board of Directors in 2008 and has served as Presiding Director since 2015."We are grateful for Don's many contributions to the board over the years, particularly his wisdom and guidance in complex situations and through our phases of growth," said Adam Elsesser, board chair, president and chief executive officer of Penumbra. "We also thank Don for his steadfast leadership and dedication to helping Penumbra advance our mission of helping more and more people over the years."Mr. Kassing is President Emeritus of San Jose State University

Investing.com
Feb 19th, 2025
UBS raises Penumbra stock price target to $320, keeps buy rating

Penumbra plans to expand its manufacturing capacity with a new facility in Costa Rica.

PR Newswire
Feb 18th, 2025
Penumbra, Inc. Reports Fourth Quarter And Full Year 2024 Financial Results

ALAMEDA, Calif., Feb. 18, 2025 /PRNewswire/ -- Penumbra, Inc. (NYSE: PEN), the world's leading thrombectomy company, today reported financial results for the fourth quarter and full year ended December 31, 2024. Financial Highlights: Adjusted revenue1 of $321.3 million, excluding the $5.8 million impact of the Italian government's payback provision pertaining to prior years, an increase of 12.9% adjusted2 or 13.0% in adjusted constant currency2 compared to the fourth quarter of 2023. Adjusted revenue1 of $1,200.4 million, excluding the $5.8 million impact of the Italian government's payback provision pertaining to prior years, an increase of 13.4% in adjusted2 and adjusted constant currency2 compared to the full year 2023

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