Description
Join IQVIA Biotech, where innovation meets impact. You'll be at the forefront of 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 with sites.
- Evaluate the quality and integrity of study site practices and escalate quality issues as needed.
- Manage study progress by tracking regulatory submissions, recruitment, case report form completion and data query resolution.
- Ensure site documents are available for filing in the Trial Master File (TMF) and verify Investigator's Site File (ISF) maintenance.
- Create and maintain documentation regarding site management, monitoring visit findings and action plans.
- Collaborate with study team members for project execution support.
Qualifications
- Minimum 1-2 years of on-site monitoring experience.
- Experience monitoring Oncology studies required.
- Bachelor's Degree in a scientific discipline or healthcare preferred.
- Basic knowledge of and skill in applying clinical research regulatory requirements (GCP and ICH guidelines).
- Good written and verbal communication skills, including command of English.
Additional Requirements
- Full UK right to work required; no visa sponsorship available.
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