Clinical Contracts Analyst

🕒 il y a 1 mois

🔔 Pennsylvania – Distant

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💵 $79 400 - $119 100 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🧐 Analyste

🦅 Parrain de Visa H1B

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👻 Score fantôme 1%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of Teleflex

Teleflex

10 000+ employés

🏥 Santé

🏭 Fabrication

⚕️ Assurance santé

💰 €275 000 Venture Round en 2010-01

Healthcare • Manufacturing • Healthcare Insurance

Teleflex est un fournisseur mondial de dispositifs médicaux innovants et de solutions, dédié à soutenir les professionnels de santé et à améliorer les soins aux patients. Avec un portefeuille diversifié incluant des produits pour l'anesthésie, la médecine d'urgence, la cardiologie interventionnelle et bien plus, Teleflex vise à améliorer la santé et la qualité de vie. L'entreprise met l'accent sur son engagement envers l'éducation et le support client dans le secteur de la santé.

Description

• Facilitate negotiation, execution, and ongoing revisions of clinical study contracts and recommend contract-template language. • Serve as the primary internal and external contact for contracts and payments. • Ensure compliance with agreements and assess, recommend, and negotiate amendments, renewals, and changes to terms. • Coordinate internal legal review of contract language. • Maintain contract negotiation correspondence and agreements. • Monitor regulatory and legal changes affecting clinical study contracts and reimbursement practices. • Escalate contractual and payment issues and recommend mitigation strategies to management. • Manage the clinical compensation process, database, reporting, and payments for investigator fees, IRB oversight, and other reimbursable clinical-trial costs. • Manage contractual and financial information in clinical-trial databases. • Provide data management, analytics, reporting, and business-intelligence support for clinical trials. • Track timelines and coordinate contract and compensation requirements with project-team expectations. • Develop study compensation agreement templates and obtain approvals. • Ensure consistency among study protocols, contract templates, informed-consent language, and compensation agreements. • Collaborate on development and testing of study-payment programming. • Interface with Finance and Accounts Payable regarding payment inquiries. • Communicate negotiation and execution status to project teams and clinical management. • Develop and negotiate investigator-initiated research contracts, data-use agreements, third-party vendor clinical research contracts, and clinical consulting agreements. • Identify, present, and implement process-improvement plans with cross-functional teams. • Lead and participate in promotional and other materials processes to ensure complete, accurate, and compliant materials.

🎯 Exigences

• 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 experience in pharmaceutical, medical device, healthcare, or Contract Research Organizations preferred. • Experience with master services agreements (MSAs), statements of work (SOWs), data use agreements (DUAs), non-disclosure agreements (NDAs), and amendments. • Understanding of regulatory requirements and documents, including CFR and GCP. • Moderate knowledge of clinical research processes, medical terminology, healthcare compliance, and privacy regulations such as HIPAA and the Sunshine Act. • Proven expertise in Microsoft Office Suite, including Word, PowerPoint, Access, Excel, SharePoint, and electronic data capture. • Basic understanding of relational databases, including query design, file manipulation, and table structure. • Ability to work in a team environment and represent the organization on specific projects. • Advanced written and verbal communication and interpersonal relationship skills. • Proven problem-solving, organizational, analytical, and critical-thinking skills. • Ability to work independently, prioritize, and work within a matrix team environment. • Willingness and ability to travel approximately 20% domestically and internationally.

🏖️ Avantages

• Medical insurance • Prescription drug insurance • Dental insurance • Vision insurance • Flexible spending accounts • 401(k) savings plan • Paid time off (PTO) • Short-term disability • Long-term disability • Parental leave

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