Senior Clinical Budget Analyst

🕒 il y a 1 mois

🗣️🇺🇸🇬🇧 Anglais requis

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Logo of Penumbra, Inc.

Penumbra, Inc.

1001 - 5000 employés

Fondée en 2004

⚕️ Assurance santé

🧬 Biotechnologie

Healthcare Insurance • Biotechnology • Medical Devices

Penumbra, Inc. est une entreprise mondiale de soins de santé, spécialisée dans le développement de technologies innovantes pour aider les patients à travers le monde. Spécialisée dans la production de dispositifs médicaux pour les conditions neurovasculaires, Penumbra propose des produits tels que des dispositifs de thrombectomie, des cathéters d'embolisation et des systèmes compatibles IRM. L'entreprise s'engage à faire progresser les soins aux patients avec des solutions logicielles de nouvelle génération comme Lightning Flash 2. 0, conçue pour l'élimination rapide des caillots sanguins et le traitement de l'embolie pulmonaire. Penumbra s'engage à améliorer les résultats pour des conditions telles que l'AVC, l'anévrisme cérébral et l'infarctus du myocarde, soutenue par des preuves cliniques et des stratégies de croissance des investisseurs.

Description

• Provide key support to the Clinical Research Department for Penumbra clinical trials • Act as a core liaison between the Clinical Research and Legal Departments within Penumbra • Lead the process of clinical study budget negotiations with the clinical study sites (e.g., hospitals) for multiple clinical studies • Develop, review, and negotiate budgets and amendments for clinical trial sites • Serve as a primary point of contact between the Clinical Research and Legal teams by submitting contract requests for clinical and investigator-sponsored studies • Provide management with regular updates on site start-up progress and strategic implications • Identify and communicate any potential or actual delays, recommending solutions to keep projects on schedule • Maintain ongoing communication with clinical project managers and study teams to provide timely status updates • Proactively identify potential issues that may arise with budget and contract negotiations and propose potential solutions or options • Provide training and support for complex budget topics to junior team members • Identify and participate in ongoing process improvement initiatives when appropriate • Partner closely with the Legal team to manage timelines and expectations for new and changing clinical studies on a regular basis • Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures • Ensure other members of the department follow the QMS, regulations, standards, and procedures

🎯 Exigences

• Bachelor's degree in life sciences, business, finance, legal, or related field with 8+ years of clinical budget or similar relevant experience, or equivalent combination of education and experience • Clinical research experience in a medical device, pharmaceutical or comparable regulated environment desirable but not essential • Strong organizational skills • Experience in creating and negotiating budgets • Familiarity with clinical trial agreements (contracts) • Ability to process a high volume of work and meet deadlines in a fast-paced environment is essential • High degree of accuracy and attention to detail necessary • Creative problem-solving skills are highly desirable • Outstanding written, oral, and interpersonal communication skills are required • Proficiency with MS Word, Excel, and PowerPoint • Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

🏖️ Avantages

• 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).

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