IQVIA is the Human Data Science Company oriented to drive human health outcomes forward.

When you join IQVIA Hungary as a sponsor-dedicated CRA, you’ll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers. Whether you're just starting out or looking to deepen your expertise, this role promises to offer intentional career growth and professional development.

With access to world-class training and mentoring, you’ll have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Job overview:

• Perform site monitoring visits (selection, initiation, monitoring and close-out)
• Work with sites to adapt, drive, and track subject recruitment plan
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Act as a mentor for clinical staff including conducting co-monitoring and training visits
• Collaborate and liaise with study team members for project execution support
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications
• Bachelor's Degree Degree in scientific discipline or health care preferred.
• At least 4 years of on-site monitoring experience
• Equivalent combination of education, training and experience may be accepted in lieu of degree
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., GCP and ICH guidelines
• Strong therapeutic and protocol knowledge as provided in company training
• Computer skills including proficiency in use of Microsoft Word, Excel and PP
• Written and verbal communication skills including fluent Hungarian and good command of English language
• Organizational and problem-solving skills
• Effective time and financial management skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

What you can expect:

Resources that promote your career growth

Leaders that support flexible work schedules

Programs to help you build your therapeutic knowledge

Dynamic work environment that exposes you to new experiences

Company car, mobile phone and attractive benefits package

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

Please apply online with your English CV and a motivation letter.

www.iqvia.com

#CRASDAJD

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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com