Clinical Contracts Analyst

🕒 5 dias atrás

❄️ Minnesota – Remoto

info

💵 $79.400 - $119.100 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🧐 Analista

🦅 Patrocina Visto H1B

info

🗣️🇺🇸🇬🇧 Inglês obrigatório

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Teleflex

10.000+ funcionários

⚕️ Seguro de Saúde

💊 Farmacêutico

💰 $275.000 Venture Round em 2010-01

Healthcare Insurance • Medical Devices • Pharmaceuticals

A Teleflex é uma fornecedora global de dispositivos e soluções médicas inovadoras, dedicada a apoiar profissionais de saúde e aprimorar o cuidado ao paciente. Com um portfólio diverso que inclui produtos para anestesia, medicina de emergência, cardiologia intervencionista e outras áreas, a Teleflex tem como objetivo melhorar a saúde e a qualidade de vida das pessoas. A empresa enfatiza seu compromisso com educação e suporte ao cliente no setor de saúde.

Descrição

• Facilitate negotiation, execution, and ongoing revisions of clinical study contracts based on substantial knowledge of financial/fair market value, regulatory, and clinical requirements while demonstrating clinical knowledge • Function as the primary internal and external contact for contracts and payments • Assure compliance with existing agreements and analyze the need for contract amendments or renewals, and make recommendations, and/or negotiate changes to terms and conditions • Facilitate and direct internal legal review of contract language as appropriate • Maintain contract negotiation correspondence and agreements in accordance with procedures • Monitor changes to regulatory and legal requirements affecting clinical study contracts and reimbursement practices, in coordination with Legal and Regulatory • Provide proper escalation of contractual and payment issues and actively engage with management to provide recommendations for mitigation • Manage the clinical compensation process, database, and related reporting, including issuance of payments for investigator fees, IRB oversight, and other reimbursable costs for clinical trials • Manage contractual and financial information in clinical trial databases with a high degree of accuracy • Provide data management, analytics, reporting, and business intelligence support for clinical trials • Track timelines and ensure contract and compensation requirements are met in coordination with project team expectations • Develop a study compensation agreement template with support from project managers and management and obtain necessary approvals • Ensure consistency with the study protocol, clinical contract template, informed consent language, and compensation agreement • Collaborate with project team members on the development and testing of study payment programming • Interface with Finance and Accounts Payable as needed on payment inquiries • Regularly communicate contract and/or compensation agreement negotiation and execution status to the project team and clinical management • Develop and/or negotiate investigator-initiated research contracts, data use agreements, third-party vendor clinical research contracts, and clinical consulting agreements upon request • Perform other duties as assigned • Identify opportunities for process improvement in collaboration with cross-functional teams; present and implement process improvement plans to management and/or key stakeholders

🎯 Requisitos

• BS/BA in a related field or equivalent experience • Experience in clinical research and related regulatory requirements • Minimum of five years’ experience in contract negotiation/administration and financial tracking/analysis against contracts • Clinical contract work experience from pharmaceutical, medical device, healthcare, or Contract Research Organizations (preferred) • Experience with contractual agreements, including master services agreements (MSAs), statements of work (SOWs), data use agreements (DUA), non-disclosure agreements (NDAs), and amendments

🏖️ Benefícios

• medical, prescription drug, dental, and vision insurance • flexible spending accounts • participation in a 401(k) savings plan • various paid time off benefits, such as PTO, short- and long-term disability, and parental leave

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