Clinical Trial Associate

vor 2 Monaten


Monheim am Rhein, Nordrhein-Westfalen, Deutschland medizinischerstellenmarkt Vollzeit
Mit über 15 Jahren Erfahrung in der klassischen Pharmaindustrie, Biotechnologie, Chemie und Medizintechnik kennen wir die entscheidenden Kontaktpersonen, die anspruchsvolle Aufgaben mit Potenzial ausschreiben. Die hohe Personalnachfrage eröffnet spannende Möglichkeiten für engagierte Fach- und Führungskräfte, um sich beruflich zu entwickeln und an der eigenen Karriere zu arbeiten. Als spezialisierte Personalberatung mit einem internationalen Netzwerk bieten wir Ihnen entscheidende Vorteile – und das völlig kostenfrei für Sie. Registrieren Sie sich und profitieren Sie von interessanten und passenden Positionen und Projekten.
Entwicklung eines Trial Master File (TMF) Plans, Durchführung laufender und abschließender Qualitätskontrollen (QC) des TMF für Abschnitte, die dem Clinical Project Manager (CPM) gehören Versorgung der Clinical Research Organisation (CRO) oder des Partners mit Rückfragen/Feedback, um die Richtigkeit und Vollständigkeit der Dokumente und des TMF insgesamt sicherzustellen Unterstützung des Program Delivery Lead (PDL)/CPM bei der Einrichtung von Studien im Clinical Trial Management System (CTMS) Bereitstellung von Informationen für das CTMS-Team Durchführung laufender und abschließender Qualitätskontrollen des CTMS Verbindung zwischen Partnern, CPM, Studienärzten, Clinical Development Quality (CDQ) und der Rechtsabteilung Beantragung der Einrichtung von Studienpostfächern für alle Studien und Sicherstellung der Zugangsverwaltung Zusammenarbeit mit CPM Unterstützung von Audit-/Inspektionsaktivitäten und Unterstützung des Clinical Development Quality Lead (CDQL) Teilnahme an Sitzungen des klinischen Studienteams und/oder anderen prüfungsbezogenen Sitzungen
Ein abgeschlossener naturwissenschaftlicher Hochschulabschluss Berufserfahrung in einem Arbeitsumfeld der klinischen Entwicklung Gute Englischkenntnisse in Wort und Schrift Kenntnisse der Guten Klinischen Praxis (GCP) und der Richtlinien des Internationalen Rates für die Harmonisierung der technischen Anforderungen an Humanarzneimittel (ICH), der Food and Drug Administration (FDA) und/oder der Vorschriften der Europäischen Union (EU) Ausgezeichnete Kommunikationsfähigkeiten und Liebe zum Detail Sehr gute Kenntnisse der Microsoft Office Suite
Betreuung im gesamten Bewerbungsprozess Betreuung im laufenden Projekt durch unser Team
Ihr Kontakt Referenznummer 774824/1 Kontakt aufnehmen Telefon: E-Mail: Anstellungsart Anstellung bei der Hays Professional Solutions GmbH

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