Clinical Study Manager

🕒 May 23

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Penumbra, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology • Medical Devices

Penumbra, Inc. is a global healthcare company focused on developing innovative technologies to help patients worldwide. Specializing in the production of medical devices for neuro and vascular conditions, Penumbra offers products such as thrombectomy devices, embolization catheters, and MRI-compatible systems. The company is dedicated to advancing patient care with next-generation software solutions like Lightning Flash 2. 0, designed for the rapid removal of blood clots and treatment of pulmonary embolism. Penumbra is committed to improving outcomes for conditions like stroke, brain aneurysm, and heart attack, supported by clinical evidence and investor growth strategies.

📋 Description

• 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

• 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

• 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).