Senior Clinical Research Associate

🕒 vor 10 Tagen

🇵🇱 Polen – Remote

💵 zł129.750 / Jahr

⏰ Vollzeit

🟠 Senior

🧪 Wissenschaftler Klinische Forschung

👻 Geisterscore 0%

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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Pfizer

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1849

💼 Beratung

📣 Marketing

💊 Pharmazie

💰 Post-IPO Debt im 2023-05

Consulting • Marketing • Pharmaceuticals

Wir feiern 175 Jahre mutige wissenschaftliche Innovation – und wir sind noch nicht am Ende. Jeden Tag lenken wir unsere Leidenschaft und Ressourcen darauf, innovative Therapien zu entwickeln, die das Gesicht des Gesundheitswesens verändern. Lassen Sie uns den gestrigen Tag übertreffen.

Beschreibung

• Manage, monitor and close out assigned clinical trial investigator sites • Ensure proper clinical trial conduct according to the Study Monitoring Plan, applicable laws, Good Clinical Practices and Pfizer standards • Manage operational implementation of clinical trial activities from site initiation through database lock • Serve as primary contact for assigned investigator sites during study conduct • Facilitate information flow among study team members, vendors and investigator sites • Perform investigator site development, coaching and training of site personnel • Attend investigator meetings when required, virtually or face-to-face • Support enrollment and resolve site activation and recruitment issues • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and closure • Monitor site-level AEs and SAEs and follow up with investigators to resolve reporting issues • Submit required reports, documentation, updates and tracking within required timeframes • Identify and resolve investigator site issues and develop corrective and preventive actions • Resolve data queries and prepare and conduct site close-out activities • Oversee investigational product receipt, handling, accounting, storage and destruction • Support database release as needed • Undertake unblinded monitor responsibilities where required • Maintain product, protocol and therapy-area knowledge and interact with healthcare professionals • Support the study clinician on patient safety, eligibility and clinical guidance • Drive Quality Event remediation and support audits and CAPA activities when applicable • Mentor and train Clinical Research Associates • Serve as SME for CRA-related processes • Participate in regional or local working groups and process improvement initiatives • Perform pre-activation activities including feasibility, site selection, PTA, activation checklist coordination, ICD finalization and SIV • Conduct co-monitoring activities as requested

🎯 Anforderungen

• Experience and capability to perform site management, site monitoring and close-out of assigned clinical trial investigator sites • Knowledge of applicable prevailing laws, Good Clinical Practices and Pfizer standards • Ability to manage investigator site relationships and clinical trial delivery • Ability to resolve protocol-related issues • Ability to conduct onsite and remote/electronic monitoring • Ability to monitor AEs and SAEs and collaborate with the Drug Safety Unit • Ability to manage Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment, clinical supplies, study progress and metrics • Thorough understanding of the product, protocol and therapy area • Ability to support patient safety, eligibility and clinical guidance to investigators • Ability to drive Quality Event remediation and Audit Observation CAPA development and checks when applicable • Ability to mentor/train Clinical Research Associates • Ability to serve as an SME for CRA-related processes • Ability to perform feasibility, site selection, PTA, site activation checklist coordination, ICD finalization and SIV activities under guidance of a Site Care Partner • Ability to conduct co-monitoring activities as requested

🏖️ Vorteile

• Annual bonus: 15% • Medicover • Multisport • Life insurance • Private pension plan • Other corporate benefits as per Pfizer Pay Policy • Flexible workplace culture supporting work-life harmony • Reasonable adjustments for disability inclusion