Description
At IQVIA, our Clinical Functional Service Partnership (CFSP) model offers the best of both worlds: the variety and sponsor-level exposure of working as an embedded member of a leading pharmaceutical or biotechnology team, backed by the stability, global infrastructure, and career support of IQVIA.
You'll develop deep, specialist expertise on a dedicated program, with the flexibility to expand across sponsors and therapeutic areas as your career progresses - and the security of a long-term IQVIA career even as individual programs evolve.
Through our long-standing partnerships with the world's leading pharmaceutical and biotechnology companies, you'll contribute to clinical research programs that bring innovative treatments to patients worldwide, working across all phases of development and a broad range of therapeutic areas, within a culture that supports flexibility, continuous learning, and wellbeing.
Key Responsibilities:
- Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, GCP, ICH 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 (ISF), Trial Master Files (TMF), 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.
What you'll bring:
- University degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related discipline, or equivalent combination of education and experience.
- 1.5 years on-site monitoring experience of clinical trials within a CRO, pharmaceutical, biotechnology, or healthcare environment.
- Strong knowledge of GCP, ICH guidelines, and applicable regulatory requirements.
- Preferable experience in a sponsor-dedicated or cFSP environment.
- Knowledge of patient recruitment and study start-up activities is preferred.
- Excellent communication, organizational, and stakeholder management skills.
- Fluent written and verbal communication skills in local language (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.