Senior Site Activation Specialist - EMEA/US experience required
PL
PRA Health Sciences
Req #: 118088
Type: United Kingdom
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Overview: Job title - Senior Study Site Specialist Location - countries listed on the advert (UK, Poland, Spain, Romania, Bulgaria and Serbia) Sponsor dedicated As a Senior Study Site Specialist you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities: Working fully embedded within an ever expanding program that specializes in the Oncology space, you will be responsible for conducting end-to-end site start-up from feasibility to site closure serving as the primary point of contact for the site, country and the study team Additional responsibilities include: * Participate in study-specific site management meetings. * Utilize tools to track activities and develop reports. * Responsible for essential document collection, tracking & review. * Responsible for the collection of country and site level intelligence. * Responsible for Institutional Review Board/ Ethics Committee submissions for the country. * Support Regulatory Authority submissions. * Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a study as appropriate. * Manage site-level Regulatory Green Light processing. * May serve as an In-House Study Lead on limited-scope studies, a primary point of contact to study team on end-to-end study activity. May serve as In-House Study Lead at a regional or country level. * Lead study-specific site management meetings as appropriate. * Oversee essential document collection, tracking & review. Qualifications: To be successful in this role, you must have: * Preferred BA/BS degree in Business Administration, science or related field, or additional relevant experience.. * At least 5 years' of relevant experience in the biopharmaceutical/CRO industry. * Strong presentation, documentation, and interpersonal skills. * Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet. * Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment. * Excellent oral and written communication skills. * Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel. * Thorough understanding of FDA and/ or EU Directives and Regulations, ICH Guidelines and various country/local regulatory requirements. * Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines. 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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. 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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