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IQVIA

Runs drug trials and sells health data to pharma

Clinical Research Associate FSP

Clinical Research OperationsPosted on Nov 11
Full-timeSofia, BulgariaNo salary listed

About the Job

Requirements

  • A university degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related discipline, or an equivalent combination of education and experience.
  • At least 1 year of on-site clinical trial monitoring experience within a CRO, pharmaceutical, biotechnology, or healthcare environment.
  • Strong knowledge of Good Clinical Practice, International Council for Harmonisation guidelines, and applicable regulatory requirements.
  • Fluent written and verbal communication skills in the local language at a minimum C1 level, along with a strong command of English.
  • Ability to work independently, manage multiple priorities, and collaborate effectively within cross-functional teams.
  • Willingness to travel within the assigned region up to 40–60% of working time.
  • A valid Class B driver's license.

Responsibilities

  • Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, Good Clinical Practice, International Council for Harmonisation guidelines, and applicable regulatory requirements.
  • Ensure investigational sites maintain high standards of patient safety, data integrity, protocol compliance, and study quality.
  • Build and maintain effective relationships with investigators and site personnel, providing ongoing guidance, training, and support throughout the study lifecycle.
  • Monitor study progress, including regulatory documentation, patient recruitment and enrollment, data query resolution, and site performance metrics.
  • Collaborate with sites to implement and optimize patient recruitment and retention strategies to support study timelines.
  • Maintain accurate, complete, and inspection-ready study documentation, including Investigator Site Files, Trial Master Files, monitoring reports, and follow-up communications.
  • Identify, assess, and appropriately escalate study risks, site issues, and quality concerns while driving timely resolution.
  • Partner closely with cross-functional study teams to support successful study execution and delivery of project objectives.
  • Mentor and support junior clinical team members through coaching, training, and co-monitoring activities, as applicable.
  • Contribute to continuous improvement initiatives and support study start-up, maintenance, close-out, and site financial activities as required.

Desired Qualifications

  • Experience in a sponsor-dedicated or clinical Functional Service Partnership environment.
  • Knowledge of patient recruitment and study start-up activities.

About the Company

IQVIA

Runs drug trials and sells health data to pharma

IQVIA runs clinical trials for drug, biotech and medical device companies and sells them the health data, software and analytics they use to develop and market treatments. Its research arm designs studies, recruits trial sites and patients, and manages trials through to regulatory filing. Its commercial arm sells market data, consulting and software that pharma sales and marketing teams use to plan product launches. Clients pay through multi-year service contracts and data and software subscriptions. IQVIA was formed in 2016 when clinical research firm Quintiles merged with health data company IMS Health, and it is based in Durham, North Carolina.

Company size
10,001+
Company stage
IPO
Headquarters
Durham, NC
Founded
1998

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