Manager, Clinical Affairs

🕒 Novembro 3

❄️ Minnesota – Remoto

❄️ Minnesota – Remote

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

👻 Score fantasma 11%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 8 dias.
• As vagas desta empresa costumam ser preenchidas em 47 dias.
• Sem salário divulgado.

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Saluda Medical

SiteLinkedInTodas as Vagas

201 - 500 funcionários

🏥 Saúde

💼 Consultoria

🏭 Manufatura

Healthcare • Consulting • Manufacturing

A Saluda Medical é uma empresa pioneira no campo da neuromodulação, focada no desenvolvimento de plataformas inovadoras para tratar condições neurológicas crônicas. Eles criaram o Evoke® System, alimentado por sua tecnologia proprietária SmartLoop™, projetada para medir biomarcadores únicos dos pacientes e ajustar continuamente a estimulação para manter a consistência terapêutica. A Saluda Medical está liderando o caminho na transformação do cuidado ao paciente por meio de pesquisa e desenvolvimento inovadores, e seus sistemas são amplamente reconhecidos por suas capacidades avançadas em terapia de estimulação da medula espinhal.

Descrição

• Contribute to formulating the clinical research and evidence generation strategy • Plan, implement, manage, and report applicable clinical studies and associated regulatory activities • Collaborate with Research and Development, Marketing, Clinical Operations, Medical Affairs, Regulatory Affairs, Quality, and Operations • Enable global market access and adoption of a Class III implantable electrical stimulation therapy • Drive program execution to meet customer needs and financial goals • Create and uphold a high-performance culture centered on customer focus, creative problem solving, transparency, and partnership • Develop, maintain, and optimize the clinical quality system, clinical regulatory requirements, and data integrity/quality • Establish detailed program plans and drive execution toward established objectives • Assess risk and implement strategies to ensure successful delivery of clinical objectives • Direct and collaborate with internal and external staff and liaise with partner sites and physicians • Develop protocols, statistical analysis plans, reports, and other clinical study documentation • Contribute to strategic direction for clinical affairs objectives and processes • Support manuscripts, abstracts, data presentations, and health economic value initiatives • Lead issue identification and resolution

🎯 Requisitos

• 5+ years direct clinical and regulatory experience in medical devices, including some experience with Active Implantable Medical Devices • Demonstrated success in designing and conducting clinical trials in support of medical devices and/or pharmaceuticals • Experience with neurostimulation industry preferred • Experience working with FDA and/or other regulatory and governmental agencies desired • Experience synthesizing complex clinical data into understandable written format • A minimum of a Bachelor’s degree in science, biomedical, or health-related field • Masters or PhD preferred • Ability to work effectively across time zones and cultures • Ability to travel domestically (10% of time) and internationally • Excellent verbal and written communication • Knowledge of ICH/GCP and FDA medical device regulations • Knowledge of research design, data analysis, and biostatistics • Ability to develop good interpersonal relationships with medical professionals • High degree of personal integrity • Excellent organizational skills and attention to detail • Self-motivated and independent work style with the ability to initiate and follow through on assignments • Knowledge of electronic data capture systems and web-based clinical trial management tools • Ability to think creatively and dynamically and foster a culture of commitment to thoughtful science

🏖️ Benefícios

• Ability to work effectively across time zones and cultures • Ability to travel domestically (10% of time) and internationally • Diversity and equal opportunity workplace commitment

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