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