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IQVIA Holdings Inc. is seeking a coordinator to manage study activities from site activation through close-out. You will work with a core team to ensure timely enrolment, data integrity and regulatory adherence, liaising with sponsors and internal teams for real-time updates.
The role emphasizes collaboration across disciplines, ongoing monitoring of protocols and deviations, and ensuring high standards of quality and patient safety in a fast-paced environment.
Responsible for the set-up and co-ordination of clinical study activities from site activation through to close-out, working with a core study team to ensure effective study delivery. Oversight of study timelines & performance, responding to adjusted strategies as required alongside the Study Recruiter. Liaise with the Clinical Administration team to maintain real-time tracking of subject results & key study data items (e.g. GPR/TOPs), ensuring timely receipt, review & filing of the associated documentation. Collaborate with Clinical Research Associates (CRAs) during site initiation, routine monitoring, and closeout visits to ensure protocol adherence, data integrity, and regulatory compliance. Work collaboratively with a large multidisciplinary clinical team to support study initiation, participant enrolment and randomisation, particularly during the early stages of study delivery. Monitor protocol deviations to ensure timely identification & reporting in compliance with GCP and sponsor requirements. Lead root cause analysis of deviations and collaborate with clinical data management to implement corrective and preventive actions/adjustments to operational practices/staff re-training. Primary liaison with the sponsor company and other relevant internal/external parties during the clinical phase, to provide real-time updates on subject screening & enrolment progress & facilitate timely resolution of enrolment-related queries, eligibility clarifications, and protocol deviations.
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.