Thermo Fisher Scientific
Senior CRA I/II(m/w/x)
Vollzeit
Remote
Senior
Keine Angabe
Karlsruhe, München
AS
Astellas Pharma16 Tage
Study Start-Up / Site Activation Specialist(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
München
Nejo KI-Zusammenfassung
In this role, you will be the go-to expert for Study Start-Up activities, ensuring smooth site activations and compliance with regulatory standards. Your daily responsibilities will include coordinating with study teams, managing documentation, and tracking project progress.
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Anforderungen
- •Very good German and English skills, and knowledge of another European language such as Italian, Spanish, or French
- •Demonstrable experience in study start-up/site activation in more than one country
- •Extensive experience with clinical trials and their conduct
- •Good understanding of local SSU processes and requirements
- •General knowledge of drug development and ICH/GCP guidelines
- •Proven project management skills
- •Experience in cross-functional collaboration and matrix structures
- •Involvement in early development studies
- •Bachelor's degree (BA/BS) in life sciences or a comparable qualification
- •Proficient in German and English language, as well as an additional European language such as Italian, Spanish, or French
- •Demonstrable study start-up/site activation experience in more than one country is required
- •Extensive clinical trial experience and clinical trial conduct
- •Good understanding of local SSU processes and requirements
- •General knowledge of drug development and ICH/GCP guidelines
- •Proven project management skills
- •Worked cross-functionally and within matrix teams
- •Involved in early development studies
- •BA/BS degree in life science or equivalent
Bachelor-Abschluss
Berufserfahrung
ca. 4 – 6 Jahre
Deine Aufgaben
- •Support daily operations of assigned SSU activities
- •Ensure compliance with GCP/ICH guidelines and regulatory requirements
- •Communicate and coordinate with key stakeholders, including study teams
- •Identify and escalate issues related to SSU deliverables
- •Oversee site-level SSU activities from potential site list to activation
- •Collect CDA and questionnaires for site activation
- •Negotiate ICF and submit IRB/EC documentation
- •Manage IMP release and other site activation requirements
- •Generate accurate project status and financial information in tracking systems
- •Prepare study-level essential document templates
- •Assist in content preparation for regulatory submissions
- •Facilitate ICF negotiations and required escalations
- •Prepare and submit IMP release packages
Sprachen
Deutsch – verhandlungssicher
Englisch – verhandlungssicher
Italienisch – Grundkenntnisse
Spanisch – Grundkenntnisse
Französisch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Astellas Pharma erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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