Senior Clinical Budget Analyst

🕒 Maio 8

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Logo of Penumbra, Inc.

Penumbra, Inc.

1001 - 5000 funcionários

Fundada em 2004

⚕️ Seguro de Saúde

🧬 Biotecnologia

Healthcare Insurance • Biotechnology • Medical Devices

Penumbra, Inc. é uma empresa global de saúde focada no desenvolvimento de tecnologias inovadoras para ajudar pacientes no mundo inteiro. Especializada na produção de dispositivos médicos para condições neurológicas e vasculares, a Penumbra oferece produtos como dispositivos de trombectomia, cateteres de embolização e sistemas compatíveis com RM (ressonância magnética). A empresa é dedicada a avançar o cuidado ao paciente com soluções de software de próxima geração, como o Lightning Flash 2. 0, projetado para a remoção rápida de coágulos sanguíneos e o tratamento da embolia pulmonar. A Penumbra está comprometida em melhorar os desfechos de condições como AVC, aneurisma cerebral e infarto agudo do miocárdio (IAM), sustentada por evidências clínicas e por estratégias de crescimento voltadas a investidores.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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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