CRA / Study Start-up Manager (M/F/D)

Tasks:

• Lead and coordinate Ethics Committee submissions for an observational, multi‑country study in Chile, Argentina, and Brazil.

• Provide centralized oversight to ensure quality, consistency, and adherence to timelines.

• Drive start‑up activities, including site contract management and country‑specific regulatory requirements.

• Manage stakeholder communication and ensure alignment across LATAM teams.

• Coordinate follow‑up with local teams and ensure efficient resolution of queries.

Qualification:

• Several years of experience in CRO environment, ideally in SSU / Regulatory roles.

• Strong hands‑on experience with observational studies and multi‑country submissions.

• Demonstrated expertise in EC submissions in Chile, Argentina, and Brazil.

• Excellent coordination, planning, and communication skills.

• Ability to work independently under tight timelines.

Requirements:

• English: Advanced level

• Spanish: Good working level (preferred)

• Portuguese: Good working level (preferred)

• Strong knowledge of LATAM regulatory landscapes

• Start‑up / Site Contract Management experience

Start: asap (latest end of January 2026)

Duration: 3 months

Capacity: Approx. 30 hours total

Location: Remote; Focus countries: Brazil – Chile – Argentina