Senior Clinical Research Associate (m/w/d), Single Sponsor

Ims Health SAU; Frankfurt am Main; Hybrid; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen im Bereich klinische Forschung sucht einen Senior Clinical Research Associate, der die Möglichkeit hat, seine Karriere in einem dynamischen Umfeld voranzutreiben. Diese Rolle bietet die Chance, an verschiedenen therapeutischen Bereichen zu arbeiten und direkten Zugang zu erstklassiger Schulung und Mentoring. Mit einem starken Fokus auf berufliches Wachstum und Entwicklung werden Sie in einer unterstützenden Umgebung arbeiten, die Flexibilität und Ressourcen bietet, um Ihre Karriereziele zu erreichen. Wenn Sie leidenschaftlich an klinischer Forschung interessiert sind und eine Herausforderung suchen, ist dies die perfekte Gelegenheit für Sie.

Leistungen

Home-Office

Firmenwagen

Unfallversicherung

Karrierewachstumsressourcen

Flexible Arbeitszeiten

Qualifikationen

• Mindestens vier Jahre Erfahrung in der Überwachung vor Ort.
• Kenntnisse der regulatorischen Anforderungen in der klinischen Forschung.

Aufgaben

• Durchführung von Site-Auswahl, Initiierung, Überwachung und Abschlussbesuchen.
• Evaluierung der Qualität und Integrität der Praktiken an den Standorten.

Kenntnisse

Kommunikationsfähigkeiten

Detailgenauigkeit

Flexibilität

Fließend in Deutsch (C1)

Gute Englischkenntnisse

Ausbildung

Universitätsabschluss in Lebenswissenschaften

Ausbildung im Gesundheitswesen

Tools

Regulatorische Anforderungen (GCP, ICH)

Jobbeschreibung

Join IQVIA as a Senior Clinical Research Associate / Sr CRA (m/w/d) home-based throughout Germany in our single sponsor department, and advance your career in clinical research. You’ll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our clients. Whether you're just starting out or looking to deepen your expertise, this role promises to offer intentional career growth and professional development. With access to world-class training and mentoring, you’ll have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Your responsibilities will include:

1. Performing site selection, initiation, monitoring and close-out visits
2. Supporting the development of a subject recruitment plan
3. Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
4. Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
5. Collaborating with experts at study sites and with client representatives
6. Depending on client model there might be remote-monitoring, involvement in study start-up processes, specialization on therapeutic area (pharmaceutical product or medical devices)
7. Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included

Qualifications:

1. University Degree in life science or other scientific discipline or apprenticeship in the health care field
2. Minimum of four years of on-site monitoring experience alternatively an equivalent combination of education, training and experience
3. Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
4. Strong written and verbal communication skills, attention to detail and ability to work in a fast pace environment
5. Fluency in German on at least C1 level and a good command of English
6. Flexibility to travel up to 40-60% of working time
7. Driver’s license class B

What you can expect:

1. Resources that promote your career growth
2. Leaders that support flexible work schedules
3. Programs to help you build your therapeutic knowledge
4. Dynamic work environments that expose you to new experiences
5. Home-office, company car, accident insurance and more

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

We invite you to join IQVIA.

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