Clinical Start-Up Specialist II - Madrid (Hybrid)

Allucent; Madrid; Hybrid; EUR 42,000 - 54,000; Full time

Benefits offered by this job

Comprehensive benefits

Competitive salary

Training budget

Flexible hours

Buddy program

Career progression

Referral program

Spot bonus

Loyalty awards

Job summary

Allucent in Madrid is seeking a Start-Up Associate II to coordinate local start‑up activities for clinical trials, including RA/IEC/IRB submissions and eTMF management. The role acts as the main contact for regulatory authorities and sites during the initial phase of studies.

You will support CTAs, LOIs, budgets, and site contracts, while tracking progress in CTMS and ensuring regulatory compliance with local regulations. This is a hybrid role based in Madrid with international project exposure.

Qualifications

• Life science degree or equivalent qualification.
• 2+ years regulatory affairs experience in pharma/biotech.
• Knowledge of country/region authority submission guidelines.
• Understanding of the drug development process.
• Bilingual in Spanish and English.
• Attention to detail; team player.

Responsibilities

• Coordinate and perform local site start‑up activities and regulatory submissions (RA/IEC/IRB).
• Manage document collection and filing in the eTMF/CTMS tracking systems.
• Interact with regulatory authorities and IEC/IRB; prepare and answer questions.
• Prepare, review, negotiate, and finalize CTAs, LOIs, budgets, and site‑level contracts.
• Track milestones, maintain regulatory documentation, and communicate updates.

Skills

Regulatory affairs

CTMS

Biotech knowledge

Bilingual SP/EN

Education

Life science degree

Tools

eTMF

Job description

Allucent in Madrid is seeking a Start-Up Associate II to coordinate local start‑up activities for clinical trials, including RA/IEC/IRB submissions and eTMF management. The role acts as the main contact for regulatory authorities and sites during the initial phase of studies.

You will support CTAs, LOIs, budgets, and site contracts, while tracking progress in CTMS and ensuring regulatory compliance with local regulations. This is a hybrid role based in Madrid with international project exposure.