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Local Trial Manager(m/w/x)

IQVIA
Wien
ab 4.300 / Monat

Du übernimmst die lokale Leitung von Studien, koordinierst das Team und sorgst dafür, dass alle Daten und Dokumente den Vorschriften entsprechen.

Anforderungen

  • •Bachelor's degree in life science
  • •1-2 years of clinical trial management experience
  • •Knowledge of GCP and ICH guidelines
  • •Detailed knowledge of Austrian and German regulations
  • •Fluent German (C1) and good English skills
  • •Computer skills in Microsoft Word, Excel, and PowerPoint
  • •Effective communication and organizational skills
  • •Planning and time management skills
  • •Excellent leadership skills
  • •Flexibility for limited business travel

Deine Aufgaben

  • •Betriebliche Aufsicht über zugewiesene Protokolle
  • •Studienkoordination und Standortmanagement durchführen
  • •Lokale Leitung der Studie in mehreren Ländern übernehmen
  • •Erster Ansprechpartner für zugewiesene Studien sein
  • •Lokales Team für die Studie koordinieren und leiten
  • •Aktive Beitrag zur Prozessverbesserung leisten
  • •Schulung und Mentoring des klinischen Projektteams durchführen
  • •Einige Verantwortlichkeiten im Standortmanagement übernehmen

Deine Vorteile

Resources for career growth
Supportive flexible work schedules
Programs for therapeutic knowledge
Dynamic work environments
Home-office and accident insurance

Original Beschreibung

# Local Trial Manager (m/f/d), Single Sponsor, home-based Austria **Vienna, Austria** | **Full time** We currently offer the exciting opportunity to join the team as **Local Trial Manager (m/f/d)** in **full-time** and work **home-based throughout Austria**. In this role you will be accountable for the operational management of the component of a clinical trial. Furthermore, you will need to gain an oversight to assures achievement of trial recruitment commitment, timelines and quality standards. **RESPONSIBILITIES** * Operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. * Performing trial coordination and site management according to legal guidelines. * Responsibilities for local management of a trial (or Medical Affairs data generation activities) in one or more countries. * The LTM is the primary point of contact at a country level for assigned studies. * The LTM is responsible for coordinating and leading the local trial team in order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements. * Active contribution to process improvement; training and mentoring of the clinical project team e.g. Clinical Trial Assistants, Site Managers / CRAs. * The LTM may have some site management responsibilities. * An LTM usually performs principal responsibilities under the direct supervision of a functional manager. **REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE** * Bachelor’s or higher-level degree preferable in life science. * At least 1-2 years of clinical trial management experience. * Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. * Detailed knowledge of the Austrian and German regulations and experience with EC / CA submissions in Austria and in Germany. * Fluent languages skills in German on at least C1 level and good command of English. * Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint. * Effective communication, organizational and planning skills. * Planning, time management and prioritization skills while working on multiple projects. * Excellent leadership skills, and the ability to establish and maintain effective working relationships with coworkers, managers and clients. * Flexibility to limited business travel for client meetings on regular basis. **What you can expect:** * Resources that promote your career growth * Leaders that support flexible work schedules * Programs to help you build your therapeutic knowledge * Dynamic work environments that expose you to new experiences * Home-office, accident insurance and more * Monthly gross salary: starting at 4.300 EUR basic - an overpay according to skills and working experience is possible
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