Local Trial Manager (m/w/d), Single Sponsor

The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with the preparation and documentation of clinical research projects in different therapeutic areas.

We currently offer the exciting opportunity to join the team as Local Trial Manager (m/w/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.
• Preferable 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

We invite you to join IQVIA.

Whatever your career goals, we are here to ensure you get there!

Please apply with your English CV, motivation letter and your certificates and reference letters.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

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