Contract and Budget Specialist
TW-Taipei
PRA Health Sciences
Req #: 118892
Type: Taiwan
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Overview: As a Contract and Budget Specialist you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities: What you will be doing: * Develop Clinical Trial Agreements (CTAs) utilizing standard templates and information from Contract Information Sheets. Execute CTAs in a timely manner in order to meet expected timelines for study start-up. Liaise with the legal departments of both Bayer and contract parties so that any content changes to the CTAs are mutually agreeable, and in accordance with Bayer's legally approved standard agreement language. Participate in Study kick-off meetings to obtain necessary information required for effective CT A execution. * Solid understanding of standard contract language to enable decision making pertaining to sections of CT As when language modifications are proposed by external contract parties. If language is not compliant, discuss issues with legal and work with the legal department, sites, contractors or vendors to resolve them * Generate site budgets based on final approved country budget in preparation for distribution to sites and following up with investigators. Research medical procedure costs using local or global database in order to provide accurate data for development of the site level budgets to allow Country Lead Monitors/Study Managers to calculate the latest average costs on procedures for their new studies * Manage CTAs and see that all changes to agreements and corresponding components are updated according to Bayer legal standards and Bayer Global SOPs. Responsible for annual review of all templates with the Legal department and Local Head of Monitoring and Site Management * Manage the contract tracking database, including coordination of timely updates with respect to CTA. Verify accuracy of information and reconcile discrepancies between documents and the database. Responsible for posting of fully executed contracts in eFiliA and locally on the Clinical Operations secure drive. * Process for each study, internal approval forms and other documents which are required for compliance with the Internal Signatory Process and are also required for annual audits. * Maintain excellent communication and collaboration as point person among clinical trial site personnel (Investigator, Study Coordinator, Institution's Legal Counsel) Bayer's Head, Clinical Operations, Legal Counsel and Manager, Insurance, throughout the contract negotiation process. * Responsible for preparing for internal audits by maintaining a complete and accurate paper trail for each site contract negotiation. * Qualifications: You are: * Must have a Bachelors' degree or an equivalent scientific or commercial Higher Vocational education * Has healthcare field, pharmaceutical industry or clinical research experience * Must has full scope of site contract experience. Including initial and amendment. 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-ST1 #LI-Hybrid
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