Manager/Senior Manager, Records Management

Vaga não está no LinkedIn

🕒 Setembro 22

🏄 California – Remoto

🏄 California – Remote

💵 $110.000 - $160.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

👻 Score fantasma 0%

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• As vagas desta empresa costumam ser preenchidas em 98 dias.

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Codera

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

A Codera é uma empresa B2B que faz parceria com empresas de biotecnologia e farmacêuticas para fornecer expertise e infraestrutura de desenvolvimento de medicamentos de ponta a ponta. Ela apoia clientes em todo o ciclo de vida do desenvolvimento de medicamentos com serviços técnicos, operacionais e infraestrutura para ajudar a avançar os programas terapêuticos.

Descrição

• Review study documents received from study teams for completeness and accuracy and upload them to the Trial Master File (TMF) • Perform quality control and quality reviews of TMF documents according to SOPs, work instructions, and guidance documents • Ensure documents failing TMF quality control or review are remediated and provide best-practice recommendations • Support TMF and CTMS inspection readiness for clinical studies • Provide feedback, support, and training to study teams on quality documentation management practices • Conduct TMF educational workshops and training as needed • Address questions about document filing and TMF system use • Maintain Essential Document Lists (EDLs) • Perform secondary review of site Essential Document Packages for site activation and Investigational Product release • Maintain the Clinical Trial Management System (CTMS), including study-, country-, and site-level updates, and review entries for accuracy • Contribute to TMF QC tools and materials, including the QC Tool, QC Manual, Doc Owner Manual, and TMF newsletters • Maintain current knowledge of the TMF Reference Model, industry best practices, and applicable regulatory considerations • Assist with inspection and audit activities, including preparation and corrective action plans • Execute other duties as assigned

🎯 Requisitos

• Minimum 2 years of relevant clinical research and TMF experience required • Understanding of the clinical trial process and experience handling clinical trial-related documents required • Previous experience in electronic TMFs; Veeva preferred • Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management • Self-motivated, well-organized, detail-oriented, with excellent written and verbal communication skills • Ability to achieve high performance goals and meet deadlines in a fast-paced environment • Strong organizational skills with outstanding attention to detail and follow-through • Highly resourceful and adaptable to effectively support multiple competing demands and changing priorities • Proactive approach to problem-solving with strong decision-making capabilities • Fully proficient in MS Office Suite and internet research

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