Clinical Trial Coordinator

Thermo Fisher Scientific Inc.; Karlsruhe; Vor Ort; EUR 40.000 - 80.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen sucht engagierte Fachkräfte, die einen positiven Einfluss auf die Gesundheit der Menschen haben möchten. In dieser Rolle werden Sie Teil eines dynamischen Teams, das sich der Verbesserung von Gesundheitsprotokollen widmet. Sie werden an der Überprüfung von Daten, der Kommunikation mit Studienstandorten und der Einhaltung regulatorischer Anforderungen arbeiten. Diese Position bietet die Möglichkeit, in einem innovativen Umfeld zu arbeiten, das sich für die Entwicklung lebensverändernder Therapien einsetzt. Wenn Sie eine Leidenschaft für Wissenschaft und Teamarbeit haben, ist dies die perfekte Gelegenheit für Sie.

Qualifikationen

• Universitätsabschluss in Lebenswissenschaften oder gleichwertige Ausbildung.
• Erfahrung in der Analyse von Projektdaten zur Sicherstellung der Genauigkeit.

Aufgaben

• Durchführung von Überprüfungen der Ermittlerakten und Nachverfolgung offener Fragen.
• Überprüfung regulatorischer Dokumente auf korrekten Inhalt.

Kenntnisse

Datenanalyse

Projektmanagement

Kommunikationsfähigkeiten

Teamarbeit

Zeitmanagement

Deutsch (C1)

Englisch

Ausbildung

Universitätsabschluss in Lebenswissenschaften

Tools

Projektverfolgungstools

Jobbeschreibung

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

Our clinical department defines, develops and delivers clinical programmes. We ensure the highest-quality review of data and effective interaction with study sites, including on-site monitoring throughout a study, ensuring that patients receive needed care, as well as identifying and treating clinical trial participants.

Discover Impactful Work:

PPD clinical research service's mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our dedicated, forward-thinking and upbeat teams.

A Day in the Life:

• Performs PPD clinical research services investigator file reviews and logging of outstanding issues in project related tracking tools
• Reviews regulatory documents for proper content
• Liaises with monitor and investigative sites to resolve outstanding regulatory issues identified
• Disseminates study related information, including project tracking updates to Clients, clinical study teams and other PPD clinical research services departments
• Assists with the identification of potential investigators and development/distribution of initial protocol packets
• May assist the project team with the preparation of regulatory compliance review packages
• Builds meeting agendas and minutes, as well as coordinates team conference calls and distribution of meeting minutes

Keys to Success:

Education:

• University degree in life sciences, or equivalent in education, training and experience

Knowledge, Skills, Abilities:

Responsible for adhering to Good Clinical Practices, country specific regulations, PPD clinical research services /Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout.

• Ability to effectively analyse project specific data/systems to ensure accuracy and efficiency
• Experience of managing multiple projects with differing priorities at one given time
• Outstanding communication, teamwork, interpersonal and time management skills
• Excellent German (C1 level) and English languages