# Local Trial Management Services **Company**: IQVIA **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Seoul-Republic-of-Korea/Associate-Clinical-Project-Manager_R1517027?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_2422548f-fb4 ## Description Local Trial Management services provides local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities. Further, services will ensure the local trial team is delivering quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Clinical Research Associate (CRA) and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery at the country level. **Essential Functions** - Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report. - Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing input to study level documents and leading/coordinating local team activities in compliance with SOPs, other procedural documents and applicable regulations. - Act as primary company contact for assigned trial at the country level, may attend/participate in Investigator Meetings as needed. - Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. - Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target. - Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. - Ensures high standards for study monitoring by conducting quality local trial team meetings and facilitating CRA training, when needed. - Contributes to patient understanding of protocol and patient safety by preparing country specific informed consent in accordance with procedural document/templates. - Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate. - Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management. - Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements and developing therapeutic knowledge enough for role and responsibilities. - With focus on quality and compliance, will work closely with CRA to ensure CAPA is implemented for audits/inspections or any quality related visits. - Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. - Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals in cooperation with the local Start Up team, if as applicable. **Education and Experience Requirements:** - BA/BS degree. - Degree in a health or science related field. - 2 years of local trial management or mutually agreed clinical trial experience. - 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. - Proficient in speaking and writing the country language and English. ## Skills ### Required - ICH-GCP - clinical trial management - regulatory compliance - vendor management - study monitoring --- Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Seoul-Republic-of-Korea/Associate-Clinical-Project-Manager_R1517027?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)