IQVIA Biotech is seeking to ensure the successful execution of clinical trials by monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations.
Requirements
- Strong understanding of GCP, ICH guidelines, and regulatory requirements.
- At least 1 year of on-site monitoring experience.
- Experience monitoring in oncology solid tumor.
- Bachelor’s degree in life sciences or health-related field (or equivalent experience).
Responsibilities
- Conduct all types of site visits—selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
- Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
- Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
- Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
- Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
- Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.
- Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.
Other
- Ability to travel as required by the project.
- Bachelor’s degree in life sciences or health-related field (or equivalent experience).
- Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
- Must have experience monitoring in oncology solid tumor.
- IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
