Clinical Data Manager – FSP

🕒 il y a 18 jours

🇬🇧 Royaume-Uni – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🧪 Chercheur Clinique

🇬🇧 Parrain de Visa de Travailleur Qualifié UK

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👻 Score fantôme 20%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of IQVIA

IQVIA

10 000+ employés

💼 Conseil

🏭 Fabrication

📣 Marketing

💰 €1 000 000 000 Post-IPO Debt en 2023-05

Consulting • Manufacturing • Marketing

IQVIA est un leader mondial dans le domaine de l'analyse de données et des solutions technologiques, dédié à l'amélioration des résultats de santé. L'entreprise utilise sa plateforme Connected Intelligence pour exploiter la puissance des analyses de données avancées et de l'intelligence artificielle, favorisant ainsi l'innovation dans le secteur de la santé. IQVIA se concentre sur divers domaines, y compris la recherche clinique, la technologie et les services de conseil, afin de résoudre des défis complexes dans le domaine de la santé et d'accélérer la livraison de nouvelles thérapies aux patients.

Description

• Perform activities pertaining to the conduct of Phase I-III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and relevant procedures and guidelines • Ensure assigned trials are delivered on time, within budget, and with the highest achievable quality from a data management perspective • Participate as the primary data management representative on multidisciplinary project teams • Communicate key clinical data management metrics and determine appropriate actions with the study team • Review, develop, and/or write clinical trial documents and manuals, including Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans, and eCRF Completion Guidelines • Participate in User Acceptance Testing and Quality Control as needed • Work with Clinical Database Programmers to develop Data Flow Charts, Data Transfer Specifications, and Import Guidelines • Assist with site and third-party vendor training on CDM-related topics • Provide data review training and guidance to Sr. Clinical Data Coordinators • Perform data review and discrepancy resolution as needed • Archive trials and associated documentation upon completion • Ensure adherence to Good Clinical Practice and applicable local and international regulations

🎯 Exigences

• Minimum of 5 years of data management experience • Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT) is preferred • Individuals with commensurate experience will be considered • Oracle Inform EDC experience • Oncology and/or inflammatory therapeutic area experience is preferred • Project management experience within Data Management is preferred • CRO or Pharma data management experience • This role is not eligible for UK visa sponsorship

🏖️ Avantages

• Homebased work arrangement • Opportunity to work with multidisciplinary project teams • Training and guidance opportunities • Work on Phase I-III clinical trials contributing to innovative medical treatments and improved patient outcomes

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