Senior Clinical Research Associate (Medical)

TL;DR

Senior Clinical Research Associate (Medical): Coordinating and monitoring clinical trials for biotech and pharma companies with an accent on data integrity and patient safety. Focus on conducting site visits, managing TMF/eTMF documentation, and ensuring compliance with ICH/GCP regulations.

Location: Must be based in Portugal (ideally Porto or Lisbon) and available for countrywide monitoring (approximately 6 days per month).

Company

A global clinical research organization helping biotech, medtech, and specialty pharma companies transform breakthrough science into new medicines and diagnostics.

What you will do

• Deliver quality monitoring reports for sponsor approval according to Clinical Monitoring Plan timelines.
• Conduct on-site qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
• Ensure data integrity and patient safety in accordance with specific country regulations.
• Maintain Trial Master File (TMF) and electronic Trial Master File (eTMF) per ICH/GCP Section 8 guidelines.
• Plan day-to-day monitoring activities and set priorities across various clinical sites.

Requirements

• Undergraduate degree in a clinical, science, or health-related field, or status as a licensed healthcare professional.
• At least 4+ years of experience in independent monitoring and completion of a CRA training program.
• Working proficiency in both Portuguese and Spanish.
• Experience in therapeutic areas such as Cardiovascular, Oncology, Rare Diseases, or CNS (Alzheimer's & Parkinson's).
• Availability for travel to hospital sites located in Lisbon, Porto, and Coimbra.

Culture & Benefits

• Opportunities for professional growth and skill development to excel in the field.
• Flexibility and work-life balance to accommodate personal needs.
• Collaborative environment where employee ideas and voices influence work processes.
• Purpose-driven work contributing to the delivery of critical medical innovations for patients.