Local Trial Manager or Senior LTM
vor 3 Wochen
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with one single client and to manage clinical research projects in different therapeutic areas.
We currently offer the exciting opportunity to join the team as Local Trial Manager or Senior Local Trial Manager (m/w/d) in full-time and work home-based throughout Germany .
RESPONSIBILITIES
Services rendered will adhere to applicable company’s standard operating procedures (SOPs), work instructions, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc. Prepare or contribute to high level budget estimate in response to Request for Service’s followed by detailed budget proposal. Ensure overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensure services are delivered per contract. Act as primary company contact for assigned trial at the country level and ensures local/country team is tracking project progress against planned timelines and monitors patient recruitment rate to ensure that target enrollment will be met across the allocated countries. Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress. Participates in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits. Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target. Deliver competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. Contribute to patient understanding of protocol and patient safety by contributing to the review of country specific informed consent in accordance with procedural document/templates. Ensure trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate. Ensure Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable. With focus on quality, work closely with GTL MAO, CPL to ensure CAPA is implemented for audits/inspections or any quality related issues or concerns. Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets. Keep the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable. May contribute as a mentor, champion, or representative of functional area in process initiatives, as required and if applicable.REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE
Bachelor’s or higher-level degree preferable in life science. Minimum of 5 years of clinical research experience in the pharmaceutical industry or CRO, plus preferrable 2-3 years of clinical trial management experience. Strong working knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Fluent languages skills in German on at least C1 level and good command of English. Proficient in speaking and writing in both languages. Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs. Excellent decision-making and string financial management skills. Flexibility and ability to manage study teams in a virtual environment.We invite you to join IQVIA™.
Please apply with your English CV, motivation letter and your certificates and reference letters.
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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
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