Clinical Operations Project Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78mqk7

ppbClinical Operations Project Managers /b are an integral part of clinical trial delivery, working closely with clinical teams and sponsors to improve patients' lives by bringing new drugs to market faster. Within a sponsor-dedicated bFunctional Service Provider (FSP) /b model, the bClinical Operations Project Manager (COPM) /b is an essential member of the core project team, responsible for the operational delivery of clinical studies at regional level. The COPM ensures studies are conducted in accordance with contractual requirements, timelines, quality standards, and applicable regulations. This role combines hands-on clinical operations oversight with strong project coordination and stakeholder management, with a particular focus on site-facing activities, CRA functional leadership, and execution excellence. /p h3Responsibilities /h3 ul libStudy Oversight Delivery /b ul liAccountable for the execution of clinical trials in Italy and Greece, ensuring delivery according to timelines, budget, and quality expectations /li liMonitor study progress against milestones and proactively manage risks, issues, and contingencies /li liEnsure compliance with ICH-GCP, SOPs, and applicable regulatory requirements /li /ul /li libCRA Functional Management Site Engagement /b ul liProvide functional oversight and guidance to assigned CRAs, ensuring high-quality monitoring and performance /li liSupervise CRA training at study level (protocol, monitoring plan, study tools, etc.) /li liAccompany CRAs on key visits (e.g., SIVs, audits) as needed to support study conduct and site engagement /li /ul /li libQuality Compliance /b ul liReview and approve monitoring visit reports and follow-up communications /li liEnsure protocol adherence and oversee protocol deviations, root cause analyses,



and CAPA implementation /li liSupport inspection readiness and oversee audit findings resolution /li liPerform or support Study Evaluation Visits (SEVs) when required /li /ul /li libProject Coordination Stakeholder Management /b ul liAct as a key interface between sponsor and operational teams, ensuring alignment and transparent communication /li liCollaborate cross-functionally to support milestone achievement and resolution of study issues /li /ul /li libPlanning Performance Management /b ul liDevelop and maintain study plans and timelines, ensuring on-time delivery /li liOrganize regular study follow-up meetings with CRAs and stakeholders /li liProvide structured feedback on team performance and contribute to continuous improvement /li /ul /li /ul h3Required Skills and Qualifications /h3 ul liBachelor’s degree in Life Sciences or related field /li liMinimum 3+ years as Project Manager and 5+ years of clinical research experience /li liVery good knowledge of clinical trial conduct, ICH-GCP, and regulatory requirements /li liExperience in set-up and conduct of Early Phase – Phase I and Phase II Clinical Trials /li liTherapeutic area knowledge in Oncology would be an advantage /li liProven experience in site management, CRA oversight,



and cross-functional coordination /li liStrong communication and stakeholder management skills /li liAbility to manage multiple priorities in a matrix environment /li liVery good command in English language /li liStrong operational leadership and coordination capabilities /li liExcellent problem-solving and risk management skills /li liStrong attention to quality, compliance, and detail /li liHigh level of collaboration across teams, functions, and geographies /li liWillingness to work at Sponsor's office in Rome for at least 3 days per week /li /ul pIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at /p pIQVIA 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. /p pThe potential base pay range for this role, when annualized, is 53 200,00 € - 79 800,00 €. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or tempo parziale). 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. /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78mqk7