Trial Master File Manager

🕒 vor 1 Monat

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Vollzeit

🟠 Senior

🔴 Experte

👔 Manager

👻 Geisterscore 10%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAlle Stellen

501 - 1000 Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

💰 €450.000.000 Post-IPO Debt - BioCryst Pharmaceuticals im 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. ist ein global tätiges Biotechnologieunternehmen, das sich auf die Entdeckung, Entwicklung und Vermarktung neuartiger oraler kleiner Moleküle und Proteintherapeutika für seltene Krankheiten, insbesondere hereditäres Angioödem (HAE), konzentriert. Seit seiner Gründung im Jahr 1986 nutzt BioCryst strukturgeleitetes Wirkstoffdesign, medizinische Chemie und fortschrittliche Technologien, um erstklassige oder best-in-class Medikamente zu entwickeln, und arbeitet eng mit Patienten, Interessengruppen und globalen Partnern zusammen, um Behandlungen auf den Markt zu bringen.

Beschreibung

• 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

🎯 Anforderungen

• 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