Remote Start-Up Associate Contractor (0.5 FTE)

Allucent; Madrid; Hybrid; EUR 24.000 - 36.000; Teilzeit

Benefits dieser Stelle

2 days in office per week

Zusammenfassung

Allucent is seeking a Start-Up Associate Contractor (0.5 FTE) to join its A-team on a hybrid/remote basis in Madrid. You will coordinate local site start-up activities, manage regulatory submissions, and liaise with RA/IEC/IRB, investigators and sites through the early phase of a clinical study.

Responsibilities include maintaining documents in CTMS/eTMF, preparing regulatory packs, negotiating contracts and budgets, and ensuring compliance with local requirements.

Qualifikationen

• Life science degree or equivalent qualification.
• More than 5 years of experience in regulatory affairs in the pharmaceutical/biotech industry.
• Experience with contract negotiation.
• Thorough knowledge of country/region submission and reporting requirements and guidelines.
• Understanding of the drug development process.
• Fluent in Spanish and English.

Aufgaben

• Coordinate local site start-up activities in CTMS/eTMF and ensure timely data capture.
• Prepare, submit and maintain regulatory documentation for local trials; interact with RA/IEC/IRB.
• Prepare, review and finalize Clinical Trial Agreements (CTAs) and site contracts; manage budgets.

Kenntnisse

Regulatory affairs

Contract negotiation

Biopharma knowledge

Spanish & English fluency

Attention to detail

Team player

Ausbildung

Life Science degree or equivalent

Jobbeschreibung

Allucent is seeking a Start-Up Associate Contractor (0.5 FTE) to join its A-team on a hybrid/remote basis in Madrid. You will coordinate local site start-up activities, manage regulatory submissions, and liaise with RA/IEC/IRB, investigators and sites through the early phase of a clinical study.

Responsibilities include maintaining documents in CTMS/eTMF, preparing regulatory packs, negotiating contracts and budgets, and ensuring compliance with local requirements.