The Force CT GmbH
REGULATORY AFFAIRS MANAGER(m/w/x)
Vollzeit/Teilzeit
mit Homeoffice
Keine Angabe
Berlin
IQ
IQVIA Biotech13 Tage
Clinical Associate Submissions – Regulatory(m/w/x)
Vollzeit
mit Homeoffice
Junior
Keine Angabe
Berlin
Nejo KI-Zusammenfassung
In this role, you will lead complex projects and ensure compliance with regulations while managing site activation activities. Your day-to-day responsibilities will include preparing submission documents, conducting feasibility studies, and mentoring junior team members.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
Anforderungen
- •EU CTR experience for Germany and Austria
- •Local language proficiency
- •Knowledge of national requirements
- •B Sc degree in Health Sciences or related field
- •1 - 3 years' relevant clinical research experience
- •Experience in EUCTR and CTIS submission procedures
- •Feasibility and Country Inform Consent adaptation for DACH regions
- •Experience in Site Contract negotiations with DACH sites
- •Experience in medical device submissions is beneficial
- •In-depth knowledge of clinical systems, procedures, and corporate standards
- •Good negotiating and communication skills in local language
- •Effective communication, organizational, and interpersonal skills
- •Ability to work independently and to effectively prioritize tasks
- •Ability to manage multiple projects
- •Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- •Understanding of regulated clinical trial environment and knowledge of drug development process
Bachelor-Abschluss
Berufserfahrung
1–3 Jahre
Deine Aufgaben
- •Perform country-level tasks for Site Activation activities
- •Ensure compliance with local and international regulations
- •Adhere to standard operating procedures (SOPs) and project requirements
- •Prepare and submit documents to regulatory bodies
- •Conduct feasibility and site identification activities
- •Manage site activation activities according to regulations and SOPs
- •Distribute completed documents to sites and project team members
- •Review site documents for completeness and accuracy
- •Track and follow up on document approvals and executions
- •Inform team members of document completion for individual sites
- •Provide local expertise to Site Activation Managers and project teams
- •Perform quality control on documents from sites
- •Act as a subject matter expert on specific topics
- •Mentor junior Clinical Associates
Sprachen
Deutsch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens IQVIA Biotech 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.
Ähnliche Jobs direkt in deine Inbox?
Noch nicht perfekt?