Clinical Study Manager

Penumbra, Inc.

Clinical Study Manager providing leadership in the planning, design, and execution of clinical studies at Penumbra. Responsible for managing timelines, budgets, and study-related documents.

Posted 5/23/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $123,000 - $170,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provides leadership in the planning, design, and execution of clinical studies sponsored by Penumbra to assess safety and effectiveness of products.
Works with confidential subject and company data, and interfaces with a variety of internal and external stakeholders.
Develops/maintains project timeline inclusive of startup through completion.
Drives development, approval, and distribution of study-related documents and study tools for investigational sites and review committees.
Manages distribution, collection and tracking of regulatory documentation to help ensure audit readiness.
Negotiates study budgets with sites, Core Labs, and other vendors.
Attends site visits as necessary.
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 and study manuals.
Monitors progress of studies, identifies study-related trends/issues and implements corrective actions when necessary.
Represents the Clinical Affairs Department on cross-functional meetings and projects as needed.

Requirements

What you’ll need

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)
Field experience preferred
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

Benefits

Comp & perks

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).

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial experienceproject managementregulatory documentationstudy-related documentsdata managementproblem solvingmedical terminologyaudit readinessvendor managementstudy metrics tracking

Soft Skills

leadershipinterpersonal communicationattention to detailorganizational skillscreativityteam collaborationprioritizationprocess improvementnegotiationfluency in English