Senior Clinical Research Associate

TL;DR

Senior Clinical Research Associate (Medtech/Pharma): Managing clinical study monitoring activities across Portugal with an accent on data integrity, patient safety, and regulatory compliance. Focus on conducting site visits, maintaining TMF documentation, and ensuring high-quality monitoring reports for diverse therapeutic areas including Oncology and CNS.

Location: Must be based in Portugal (ideally Porto or Lisbon) with an expectation of countrywide monitoring (approx. 6 days/month).

Company

A global clinical research organization helping biotech, medtech, and pharma companies bring life-changing medical innovations to patients.

What you will do

• Deliver timely monitoring reports for sponsor approval according to clinical monitoring plans.
• Conduct on-site qualification, initiation, interim, and close-out visits at investigator sites.
• Ensure data integrity and patient safety in accordance with local regulations and ICH/GCP guidelines.
• Maintain and review Trial Master File (TMF/eTMF) documentation for accuracy and completeness.
• Plan and prioritize daily monitoring activities across clinical study sites.
• Manage travel expenses in compliance with company guidelines.

Requirements

• Undergraduate degree in a clinical, science, or health-related field or equivalent professional experience.
• Minimum 4+ years of independent clinical monitoring experience.
• Working proficiency in both Portuguese and Spanish.
• Ability to travel for countrywide monitoring (approx. 6 days per month).
• Experience in therapeutic areas such as Cardiovascular, Oncology, Rare Diseases, or CNS.
• Completion of a CRA training program.

Culture & Benefits

• Opportunities for professional growth and skill development.
• Flexible work environment designed to support work-life balance.
• Collaborative culture where individual ideas and voices are valued.
• Contribution to meaningful medical innovations that improve patient lives.