At a Glance
- Tasks: Conduct site monitoring visits and ensure compliance with clinical trial protocols.
- Company: Join IQVIA, a leader in clinical research and healthcare intelligence.
- Benefits: Access to world-class training, career development, and competitive salary.
- Other info: Flexible travel opportunities and a dynamic work environment.
- Why this job: Make a real impact on innovative medicines and improve patient outcomes.
- Qualifications: Experience in clinical trial monitoring and knowledge of GCP and ICH guidelines.
The predicted salary is between 51750 - 63250 £ per year.
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
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 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.
Collaborate and liaise with study team members for project execution support as appropriate.
Qualifications:
- A minimum of 18 months of independent on-site monitoring.
- You have successfully managed multiple clinical trial protocols across diverse investigative sites.
- In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Life science degree educated or equivalent industry experience.
- Flexibility to travel to sites.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Clinical Monitoring Associate in England employer: IQVIA LLC
At IQVIA, we pride ourselves on being an exceptional employer, particularly for those in the field of Pharmaceutical Development. Our Cambridge location fosters a collaborative and innovative work culture, where you will have the opportunity to influence scientific direction, mentor junior scientists, and engage directly with clients. With a strong focus on employee growth and the integration of cutting-edge AI-enabled approaches, we are committed to supporting your professional development while making a meaningful impact in the pharmaceutical industry.
