Clinical Research Manager | MedTech and IVD

Location: Spain (Remote with occasional in‑person activities)
Employment Type: Full‑time

Role Summary
We are seeking an experienced Clinical Research Manager to lead and coordinate clinical studies for medical devices and in vitro diagnostics. The role covers the full clinical lifecycle, from early study design and start‑up through execution and close‑out, in compliance with GCP, ISO standards, and applicable European and local regulations.
You will act as a key interface between sponsors, study sites, and internal teams, ensuring high‑quality delivery, regulatory compliance, and effective project and people management. This role also includes mentoring and development responsibilities for junior team members and consultants.

Key Responsibilities
You will:
• Lead and manage Clinical Investigations and Performance Studies for medical devices and IVDs from start‑up to close‑out
• Ensure studies are conducted in compliance with GCP, ISO 14155, ISO 20916, EU regulations, and local requirements
• Contribute to protocol, CRF, ICF,



and study documentation design and review
• Coordinate submissions to Ethics Committees and Competent Authorities
• Oversee site initiation, monitoring activities, and ongoing site management
• Maintain close communication with investigators, study coordinators, sponsors, and internal stakeholders
• Monitor project progress against timelines, quality metrics, and budgets
• Identify project risks and implement mitigation strategies in collaboration with the project team
• Act as the primary daily point of contact for sponsors
• Develop, maintain, and oversee Trial Master Files and eTMFs
• Prepare and present project status updates to internal and external stakeholders
• Negotiate contracts with study sites, vendors, and service providers
• Manage project finances according to sponsor contracts and approved budgets
• Provide input into proposals, budgets, and bid defense activities
• Ensure adherence

📌 Clinical Research Manager | Medical Device and IVD (España)
🏢 MDx CRO
📍 España