Trial Master File Manager

🕒 il y a 1 mois

🌲 North Carolina – Distant

🌲 North Carolina – Remote

⏰ Temps Plein

🟠 Senior

🔴 Expert

👔 Manager

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.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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BioCryst Pharmaceuticals, Inc.

Site WebLinkedInTous les Emplois

501 - 1000 employés

🏥 Santé

💼 Conseil

📦 Logistique

💰 €450 000 000 Post-IPO Debt - BioCryst Pharmaceuticals en 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. est une entreprise mondiale de biotechnologie spécialisée dans la découverte, le développement et la commercialisation de nouvelles petites molécules orales et de thérapies protéiques pour les maladies rares, notamment l'œdème angioneurotique héréditaire (OAH). Fondée en 1986, BioCryst utilise la conception de médicaments guidée par la structure, la chimie médicinale et les technologies avancées pour développer des médicaments de première classe ou de meilleure classe, et travaille en étroite collaboration avec les patients, les associations de patients et les partenaires mondiaux pour mettre les traitements sur le marché.

Description

• Act as the Clinical Operations Veeva Vault Clinical process owner and TMF subject matter expert • Lead development, deployment, maintenance, and continuous improvement of eTMF and CTMS processes, SOPs, Work Instructions, training materials, tools, and filing guidance • Set up, organize, maintain, and archive study-specific eTMF, CTMS records, and SharePoint repositories for Phase I–IV studies • Ensure clinical documentation is filed and archived according to SOPs, GCP, ICH guidelines, and retention requirements • Maintain inventory reports and tracking systems for archived paper records • Establish study dashboards and organize Veeva Vault Clinical reports for study-, country-, and site-level metrics and TMF health • Support integration between Veeva Vault Clinical and other clinical systems, including EDC platforms and CRO partner systems • Collaborate with Veeva Administrators on system configuration, testing, validation, and rollout of new functionality • Oversee clinical-system user access, role assignment, access reviews, and access changes • Maintain and periodically review BioCryst’s standard TMF Index • Conduct and oversee risk-based reviews of internally managed and CRO-managed TMFs; identify issues, escalate risks, track deficiencies, and implement corrective actions or retraining • Prepare for and support internal/external audits and regulatory inspections, including document retrieval, issue management, response coordination, and corrective-action verification • Develop and deliver training on TMF processes, filing expectations, system updates, regulatory and archival requirements • Serve as point of contact for TMF filing and document-management questions • Collaborate with clinical, regulatory, quality, data, safety, supply-chain, CRO, and other partners to keep TMFs current, complete, high quality, and inspection ready • Identify operational needs and implement solutions improving document quality, compliance, efficiency, and departmental effectiveness • Work independently, adapt to changing priorities, exercise judgment, and take initiative • Perform other duties as assigned

🎯 Exigences

• Bachelor’s degree with 7–10 years of relevant clinical research or pharmaceutical industry experience, including a minimum of 5 years of direct TMF/eTMF experience and demonstrated experience leading TMF processes, systems, vendor oversight, and inspection-readiness activities; or an equivalent combination of education and experience • Hands-on experience with the DIA TMF Reference Model and the Veeva Vault Clinical application, including the eTMF and aspects of the CTMS • Experience with audits, regulatory inspections, CRO oversight, system implementation, training and process improvement • Knowledge of Good Clinical Practice (GCP) regulatory requirements and International Conference on Harmonization (ICH) guidelines • Ability to identify team needs and suggest/implement solutions for improved departmental functionality • Must be a highly motivated self-starter who is capable of taking initiative and sees projects through to completion with minimal supervision • Must be proficient in computer software systems such as word processing, spreadsheet, and database systems