Sr. Clinical Project Manager

Sr. Clinical Project Manager – Sponsor Dedicated Clinical Project Managers provide regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. They lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones, including country & site feasibility and site selection, trial set‑up, trial execution and trial closure, and vendor set‑up activities as assigned by the Global Clinical Development Operations Trial Leader (GTL). Tasks & Responsibilities Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements. Ensure availability of required reports to support real‑time tracking of trial status according to the trial plan. Manage timely and accurate documentation and communication of trial progress. Ensure that the Study Management Team (SMT) operates in a constant state of inspection‑readiness. Act as primary contact for Country and Regional staff. Act as primary company contact for the assigned trial at the country level and ensure the local/country team tracks project progress against planned timelines and monitors patient recruitment rate to meet target enrollment across the allocated countries. This may require 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 available 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 patient understanding of protocol and patient safety by reviewing country‑specific informed consent in accordance with procedural documents/templates and managing site‑specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations. Essentials Requirements BA/BS degree. Degree in a health or science‑related field. 5 to 10 years of clinical trial management experience in the pharmaceutical industry or CRO supporting global or regional trials. Superior clinical research operational knowledge and a proven track record in successfully managing various aspects of trials from start‑up to database lock and trial closure. 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 stay away from home according to business needs. Effective leadership skills and ability to manage multiple stakeholders. Proficiency 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