---
title: 'Manager, Clinical Study Start-Up at Penumbra'
canonical: 'https://feeny.ai/job/manager-clinical-study-start-up-penumbra-united-states-c2mwe0kpvqzq'
type: 'job'
last_seen: '2026-11-08'
---

# Manager, Clinical Study Start-Up at Penumbra

- **Company:** Penumbra
- **Location:** United States
- **Work type:** remote
- **Posted:** 2026-11-03
- **Last confirmed live:** 2026-11-08
- **Apply:** https://jobs.lever.co/penumbrainc/33d7d5d2-449c-4c60-a7ba-247d52a21962

## Job description

General Summary The Manager of Clinical Study Start-Up leads the in-house Clinical Research Associate (ICRA) and Clinical Budget Analyst (CBA) teams and oversees study and site start-up activities, including regulatory documentation, site support tools, clinical site budgets, vendor management, and site activation. The role establishes and applies start-up best practices, represents Clinical Operations on cross-functional project teams, partners with our Clinical Study Management and Legal teams, and provides strategic and tactical leadership for Penumbra-sponsored clinical studies. This position is also responsible for hiring, coaching, mentoring, resource planning, and anticipating future staffing needs.

Specific Duties and Responsibilities

- Lead a team that supports study and site start-up execution, amendment submissions and approvals, activation process, and final site closure activities. *
- Lead or supervise development of study start-up materials, and other study documents, e.g., consent templates, questionnaire licensing, study manuals. *
- Lead and oversee the preparation and negotiation of initial clinical trial budgets and budget amendments with clinical study sites across multiple clinical studies. *
- Oversee and support the timely registration, maintenance, results reporting, and closure of clinical studies in publicly accessible registries, such as ClinicalTrials.gov, in accordance with applicable requirements. *
- Provide periodic updates to management regarding site start-up progress related to their strategic impact. Communicate potential or actual delays and propose actions to ensure that project timelines are met. *
- Establish, monitor, and report study start-up performance and quality metrics to identify trends, drive timely corrective actions, and support continuous improvement across clinical studies. *
- Provide oversight and guidance to clinical staff in the preparation and follow-up of Institutional Review Board (IRB) and Ethics Committee (EC) submissions, including the development and coordination of responses to review comments and request additional information. *
- Leads continuous improvement initiatives for clinical processes, systems, tools, and procedures; drives the review, development, and implementation of SOPs and work instructions; and promotes consistent compliance with applicable requirements across clinical studies. *
- Recruits, hires, and directly supervises ICRA and CBA team members, including goal setting, development planning, training, coaching, ongoing performance feedback, and performance reviews. *
- Allocates resources across studies and manages project timelines to meet departmental and company goals.*
- Identifies and escalates site- and study-related issues to management. *
- Serves as the key liaison between cross-functional teams and establishes, communicates, and aligns goals and priorities for the ICRA and CBA teams. *
- Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
- Understands relevant security, privacy and compliance principles and adheres 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. *Indicates an essential function of the role

Required Qualifications Minimum education and experience:

- Bachelor's degree in Biology, Nursing, Biomedical or Physical Sciences or related field with 7+ years of experience in preclinical research, or medical devices/pharmaceutical industry, or an equivalent combination of education and experience.
- 3+ years’ experience in the operational aspects of managing clinical studies from start-up to close-out, vendor management, and planning cross-functional operational activities required.
- Knowledge of ICH-GCPs and 21 CFR, and other relevant regulations and standards.
- Experience  creating and negotiating clinical budgets and contracts.
- Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.

Preferred Qualifications:

- Medical device experience desirable
- Strong oral, written, and interpersonal communication skills
- Excellent organizational skills, with ability to prioritize assignments while handling various projects simultaneously
- Strong computational skills; proficiency with Microsoft Office (Word, Excel, OneNote, and PowerPoint)
- Ability to apply strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts, and techniques.

Working Conditions

- General office environment
- Willingness and ability to work on site.
- May have business travel from 0% - 10%
- Potential exposure to blood-borne pathogens
- Requires some lifting and moving of up to 15 pounds
- Must be able to move between buildings and floors.
- Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
- Must be able to read, prepare emails, and produce documents and spreadsheets.
- Must be able to move within the office and access file cabinets or supplies, as needed.
- Must be able to communicate and exchange accurate information with employees at all levels daily.

Salary Range: $135,000 – $187,000 This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

## What We Offer

- A collaborative teamwork environment where learning is constant, and performance is rewarded.
- The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
- A generous benefits package for eligible employees that includes 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, and paid sick time in compliance with applicable law(s).

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.

## About Penumbra

## Company Overview
- **One-liner**: Penumbra designs, develops, manufactures and markets novel medical devices that address challenging conditions with significant unmet need, focusing on stroke thrombectomy and other vascular therapies.
- **Entity Type**: Public (NYSE: PEN)
- **Headquarters**: Alameda, California, United States
- **Founded**: 2004
- **Founders**: Arani Bose, Adam Elsesser

## Core Business
- **Primary industry**: Medical equipment manufacturing / Healthcare technology
- **Target customers**: Hospitals and healthcare providers worldwide, selling through a direct sales organization in the US, Europe, Canada, and Australia, and via distributors in other international markets.
- **Mission**: “Transform patient care through innovative therapies” and “help as many people as possible” by focusing on areas with high unmet need. [penumbrainc.com](https://www.penumbrainc.com/au/about-us/)

## Products & Services
- **THUNDERBOLT®**: The latest Penumbra CAVT™ (Computer Assisted Vacuum Thrombectomy) platform, the first cleared technology to use modulated aspiration for stroke thrombectomy. [penumbrainc.com](https://www.penumbrainc.com/)
- **Other medical devices**: A broad portfolio addressing challenging medical conditions in markets with significant unmet need, including neurovascular and peripheral vascular therapies. Products are marketed under the Penumbra brand.

## Market Standing
- **Valuation/Market Cap**: $8.1 billion (as of October 2024, per aggregated data) [linkedin.com](https://www.linkedin.com/company/penumbra-inc)
- **Key Metric**: Annual revenue of $1.4 billion (latest full year data); in Q2 FY2026 (ended June 30, 2026) revenue was $390 million, with net income of $34.8 million. [linkedin.com](https://www.linkedin.com/company/penumbra-inc)
- **Notable Investors/Partners**: Boston Scientific (listed as parent company in some data sources, though Penumbra remains an independent public company; this may be a data error). Key partners include hospitals and healthcare systems globally. Penumbra has acquired several international subsidiaries (Crossmed, Penumbra Neuro Canada, etc.). [linkedin.com](https://www.linkedin.com/company/penumbra-inc)
- **Growth Signals**: More than 4,700 employees globally (up from ~2,089 in some reports, indicating rapid hiring); available in 100+ markets; recent FDA clearance and CE Mark for THUNDERBOLT; recognized as one of the 100 Fastest-Growing Companies by Fortune in 2019. [penumbrainc.com](https://www.penumbrainc.com/au/about-us/)

## Competitive Advantages
- **First‑mover in CAVT**: THUNDERBOLT is the only cleared technology using modulated aspiration for stroke thrombectomy, creating a strong technological moat.
- **Broad global presence**: Direct sales in major markets and distribution in 100+ countries, with manufacturing and R&D in the US and Europe.
- **High‑growth, high‑impact area**: Focus on acute ischemic stroke and other critical conditions with large unmet clinical needs, driving consistent revenue growth and innovation.
- **Talent density**: Attracts many talent from top medtech companies (Medtronic, Abbott, Boston Scientific, Stryker) and retains engineers and scientists with a mission‑driven culture. [linkedin.com](https://www.linkedin.com/company/penumbra-inc)

## Strategic Focus
- **Expand CAVT platform**: Continue rolling out THUNDERBOLT globally, leveraging recent FDA clearance and CE Mark.
- **International expansion**: Strengthen presence in Latin America, Asia, and other emerging markets (e.g., Penumbra Latin America Distribuidora).
- **Organic innovation & acquisitions**: Invest in R&D and pursue strategic acquisitions to broaden the product portfolio (historical acquisitions in Canada, Sweden, Singapore, Italy).
- **Operational excellence**: Enhance manufacturing capabilities (new roles in Roseville, CA, and Alameda) to scale production of complex medical devices.

## Why Work Here
- **Purpose‑driven mission**: Employees directly contribute to saving lives and improving outcomes for patients with neurological and vascular diseases.
- **Culture of innovation**: “High‑powered innovation, cooperation, and fun” as described on the careers page; emphasis on meaningful work and collaboration. [penumbrainc.com](https://www.penumbrainc.com/about-us/careers/)
- **Global but tight‑knit**: HQ in Alameda (San Francisco Bay Area) with offices in Europe and South America; employees appreciate reverse commute and public transit options. [penumbrainc.com](https://www.penumbrainc.com/about-us/careers/)
- **Growth opportunities**: Rapidly growing headcount (over 4,700 employees) and expanding into new markets mean internal mobility and advancement.
- **Engineering & manufacturing focus**: Large technical workforce (R&D, quality, manufacturing engineering) with on‑site roles in Roseville and Alameda; many of the 64 open positions are engineering‑related. [jobs.lever.co](https://jobs.lever.co/penumbrainc)
- **Work policy**: Most roles appear to be on‑site (e.g., Manufacturing Engineer, R&D Engineer); no explicit remote policy disclosed, but the company provides reasonable accommodation for disabilities.

## Sources
1. [penumbrainc.com – Company Homepage](https://www.penumbrainc.com/)
2. [penumbrainc.com – About Us](https://www.penumbrainc.com/au/about-us/)
3. [penumbrainc.com – Careers](https://www.penumbrainc.com/about-us/careers/)
4. [linkedin.com – Penumbra, Inc. Company Page](https://www.linkedin.com/company/penumbra-inc)
5. [jobs.lever.co – Open Positions at Penumbra](https://jobs.lever.co/penumbrainc)

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