Senior Clinical Trial Manager
PRA Health Sciences
Req #: 118884
Type: Romania
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Overview: As a Clinical Trial Manager II you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities: We are looking for experienced Local/CountryStudy Managers who are interested in a sponsor dedicated role as a CTM II. In this role you will provide local management of a clinical trials in a country or countries. Responsibilities include operational oversight of assigned protocols at the country level from start‐up through to database lock and closeout activities. What you will be doing: * Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct of pre‐trial assessment visits and appropriate follow‐up of pre‐trial visit report and country feasibility report. * Collaborates with central study team for final selection of sites to participate in trial. * 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. This may require development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting. * Act as primary company contact for assigned trial at the country level, may attend/participate in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting. * Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. * Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate. * 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. * Keeps 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. Qualifications: You are: * BA/BS degree. Degree in a health or science related field. * 2 years of local trial management 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. Willingness to travel with occasional overnight stay away from home according to business needs. * Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs * Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead * Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. #LI-DS1 #LI-Hybrid
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