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Senior Clinical Research Associate (CRA) 1

iqvia · Lisbon

New
Senior 🇬🇧 English
GCP ICH guidelines Investigator Site Files (ISF) Trial Master Files (TMF)

Job description

About the role

IQVIA's Clinical Functional Service Partnership (CFSP) model offers embedded work with pharmaceutical or biotechnology teams, supported by IQVIA's global infrastructure and career support. As a Senior CRA1 in Lisbon, you will conduct site monitoring for clinical research programs across all phases of development and a broad range of therapeutic areas, mentoring junior team members and contributing to continuous improvement.

Key responsibilities

  • Conduct site qualification, initiation, monitoring and close-out visits according to study protocols, GCP, ICH guidelines and regulatory requirements.
  • Ensure sites maintain high standards of patient safety, data integrity, protocol compliance and study quality.
  • Build relationships with investigators and site personnel, providing guidance, training and support.
  • Monitor study progress, including regulatory documentation, patient recruitment and enrollment, data query resolution and site performance metrics.
  • Help sites implement and optimise patient recruitment and retention strategies.
  • Maintain accurate, inspection-ready documentation such as Investigator Site Files (ISF), Trial Master Files (TMF), monitoring reports and follow-up communications.
  • Identify and escalate study risks, site issues and quality concerns, and partner with cross-functional teams on study delivery.
  • Mentor junior clinical team members through coaching, training and co-monitoring, and support study start-up, maintenance, close-out and site financial activities.

Required profile

  • University degree in Life Sciences, Health Sciences, Nursing, Pharmacy or a related discipline, or equivalent education and experience.
  • 3-5 years of on-site monitoring experience of clinical trials within a CRO, pharmaceutical, biotechnology or healthcare environment.
  • Preferrable: experience in a sponsor-dedicated or CFSP environment, and knowledge of patient recruitment and study start-up.
  • Fluent written and spoken Portuguese (minimum C1) and strong command of English.
  • Willingness to travel up to 40-60% of working time within the assigned region, and a valid Class B driver's licence.

Required skills

  • Strong knowledge of GCP, ICH guidelines and applicable regulatory requirements.
  • Excellent communication, organisational and stakeholder management skills.
  • Ability to work independently, manage multiple priorities and collaborate in cross-functional teams.

Questions fréquentes

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Source : ats:workday

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Published 3 hours ago

Expires 1 month from now

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iqvia

Lisbon