Clinical Trial Manager
PRA Health Sciences
Req #: 118506
Type: Bulgaria
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Overview: As a Clinical Trial Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities: What you will be doing: * Owns and manages the country and site budgets of clinical studies; adheres to budget targets and agreed payment timelines * Develops, negotiates, and completes the Clinical Trial Research Agreements (CTRA) * Oversees and tracks clinical research-related payments; performs payment reconciliation at study close-out; maintains the financial systems * Provides leadership in assigned projects in terms of regulatory submissions in line with established strategies and timelines * Prepares/Reviews regulatory submission packages for initial clinical study applications and amendments to Competent Authorities and Ethics Committees according to the local and/or the EU requirements, guidelines, and laws * Ensures that regulatory deliverables for the assigned country/ies and projects are on time and with quality Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols * Proactively communicates with the assigned team members across relevant functions in order to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones * Identifies project and/or country specific problems and risks related to clinical study applications and amendments to Competent Authorities and Ethics Committees and works with internal and external team members to provide and implement solutions * Provides support and oversight to local vendors as applicable * Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems * May act as a process Subject Matter Expert (SME), share best practices, make recommendations for continuous improvement, and provide training as appropriate/required * Acts as buddy/mentor and shares best practices as appropriate/required * Performs other duties as assigned by the Functional Area Lead / direct Manager * Ability to lead a team of CTAs/CTCs as applicable Qualifications: You are: * Minimum of Bachelor's degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience * Minimum 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business * In-depth knowledge of ICH/GCP guidelines, local regulatory requirements, European regulations, and Standard Operating Procedures * Skilled knowledge of budgeting and contract negotiations, local regulatory environment, and strong understanding clinical trial registration process * Ability to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from the direct supervisor or manager * Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. Excellent problem-solving abilities: ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable * Effective and efficient organizational and time management skills in order to balance working on multiple projects in parallel * Excellent planning, analytical, project management and leadership skills * High level computer competency. Fluent in local office language and in English, both written and verbal Travel: * Ability to travel occasionally, including overnight stays as necessary, consistent with project needs and office location 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.
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