Biotech Site Monitor

Join IQVIA Biotech, where innovation meets impact.

At IQVIA Biotech, we specialise in partnering with smaller biotech and emerging biopharma companies, creating a uniquely dynamic and fast-paced environment. You'll gain early insights into groundbreaking therapies and novel diseases, often before they reach the broader scientific community.

Responsibilities

• Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plans to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication 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.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data query generation and resolution.
• Ensure 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 documentation regarding site management, monitoring visit findings and action plans.
• Collaborate with study team members for project execution support.

Qualifications

• Minimum of 1 year of on-site monitoring experience.
• Experience monitoring Oncology studies is essential.
• Bachelor's Degree in a scientific discipline or healthcare preferred.
• Basic knowledge of and skill in applying applicable clinical research regulatory requirements (GCP and ICH guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including 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.

Additional Information

This role is not eligible for UK visa sponsorship. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.