Quality Operations Manager – Contract

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

⏳ Contrat

🟡 Intermédiaire

🟠 Senior

⚙️ Opérations

👻 Score fantôme 11%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Evolution Research Group

Site WebLinkedInTous les Emplois

501 - 1000 employés

Fondée en 2014

💼 Conseil

🏥 Santé

🧬 Biotechnologie

Consulting • Healthcare • Biotechnology

Evolution Research Group est une organisation de recherche clinique dédiée à l'avancement de la science médicale par le biais d'essais cliniques innovants. Spécialisée dans des domaines thérapeutiques tels que la psychiatrie, la neurologie, la gestion de la douleur, les addictions et diverses affections chroniques, ERG collabore avec des prestataires de soins de santé et des organisations de défense pour assurer l'inclusivité et un recrutement patient exhaustif. Avec une base de données solide de participants potentiels et une expertise dans les essais de phase précoce, Evolution Research Group vise à transformer les soins de santé en soutenant le développement de thérapies révolutionnaires.

Description

• Support and, as applicable, implement quality operations initiatives supporting the company's quality management systems • Collaborate with Project Management, Regulatory, Monitoring, Information Technology/Clinical Systems, Data Management, Biostatistics/Programming, and other operational staff on study document review, data reporting, site management issues, CAPA management, issue resolution, and database build/testing • Review study documents, including protocols, informed consent form templates, study plans, CAPAs, and memo-to-files, for compliance with protocols, regulatory requirements, SOPs, and company and sponsor standards • Support Quality Operations newsletters and create quality metrics trackers • Support sponsor audits through preparation, interviews, presentations, document retrieval, audit calls/meetings, and audit finding responses • Prepare, perform, and support internal eTMF and functional-area system audits • Support contract compliance QA audits, including audit plans, document reviews, audit findings tables, and finding responses • Provide training and managerial oversight support to the Quality Operations Associate; maintain training matrices and personnel training files • Perform audits of clinical sites and clinical third-party vendors • Report to the VP of Quality Operations on audit preparation, conduct, and follow-up • Support FDA inspections, including readiness training, inspection attendance, subject matter expert interaction, document retrieval/review, and scribing • Research FDA guidance and regulatory correspondence; maintain regulatory guidance tracking and notify CRO personnel of updates • Support the company Quality Management Plan and quality deliverables, including SOPs, standard documents, work instructions, and training materials • Provide Quality Operations support to core study teams on quality issue escalation, remediation, and study document review • Facilitate and manage vendor audits and support vendor qualification/assessments

🎯 Exigences

• Bachelor's degree, preferably in a scientific/healthcare field • Minimum 5–7 years of experience in a related area • Knowledge of FDA regulatory requirements • Experience as a GCP-focused clinical QA Auditor preferred, or quality assurance experience via a clinical site, CRO, and/or sponsor • Familiarity with clinical research concepts, practices, and procedures • Strong writing, presentation, and communication skills • Strong organizational, interpersonal, and teamwork skills • Exceptional attention to detail • Ability to enter data accurately and experience working with Microsoft Office • Ability to handle multiple tasks simultaneously • Ability to work in a home environment and travel environment • Ability to travel as required by audit and inspection activities

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