CLINICAL PROJECT MANAGER

Clinical Project Manager - Clinical Project Management services provide local management of clinical trials at the country level. Services/deliverables include operational oversight of assigned projects from start-up through to closeout activities. Tasks & Responsibilities: Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, and codes of Good Clinical Practice (GCP), as well as local regulatory requirements. Prepares or contributes to high-level budget estimates in response to Request for Services, followed by detailed budget proposals. Ensures overall contract management, including review and approval of external service provider (ESP) contracts and change orders, ensuring services are delivered per contract. Act as the primary company contact for assigned trials at the country level, ensuring the local/country team tracks project progress against planned timelines and monitors patient recruitment rates to ensure target enrollment is met across allocated countries. This may require the development of local trial-specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting. Drive study compliance by maintaining and updating trial management systems, using study tools and management reports to analyze trial progress. Participate in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits. Escalate corrective and preventive actions (CAPA) to GTL MAO and CPL when the trial deviates from plans and communicate study progress and issues to study management teams and business partners. Contribute to site-level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research targets. Contribute to patient understanding of the protocol and patient safety by reviewing country-specific informed consent in accordance with procedural documents/templates. This includes reviewing and managing site-specific informed consent forms in accordance with SOPs, other procedural documents, and applicable regulations. Essential Requirements: BA/BS degree. Degree in a health or science-related field. Minimum of 3 years of local trial management experience in the pharmaceutical industry or CRO, with previous experience as a Clinical Research Associate. Specific therapeutic area experience may be required depending on the position. Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols, and associated protocol-specific procedures. Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stays away from home according to business needs. Excellent decision-making and strong financial management skills. Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate. IQVIA 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 #J-18808-Ljbffr