Senior Study Start Up Associate

Project ManagerProject ManagerFull TimeRemoteSeniorTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

Australia

Posted

12 days ago

Salary

0

Seniority

Senior

BA

Job Description

Senior Study Start Up Associate

ICON plc

Title: Senior Study Start Up Associate Location: Australia JR150637 - ICON Strategic Solutions (FSP) - Site Activation - Remote or Office About the role Experienced Study Start-Up Specialist (Global Biopharma FSP) - Home-based in Australia ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Title: Study Site Specialist Location: Sydney (Preferred), or remote in Australia Under the guidance of the Sr. Study Site Manager, this position will be responsible for conducting end-to-end site start-up from feasibility to site closures serving as the primary point of contact for the site and the study team. This includes supporting site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification, and site start-up activities. With the support of ICON right behind you, you will be joining a commercial-stage, global Biotech company, becoming part of a small team in Australia with a vision to grow the team further. With a mission to develop, manufacture and commercialize high-quality medicines for the treatment of cancer and other major diseases, you will be working on first-in-class Oncology trials. This is a unique opportunity to combine the best of both worlds (Biotech and CRO) to enter a career path that will support your growth and professional development and will broaden your expertise. You will be embedded in our client's study team and have a dedicated ICON line manager to support you. What You Will Do: You will manage day-to-day site start-up and activation activities, supporting your team to deliver quality outcomes. Key responsibilities include: - Serve as a primary point of contact to study team on end-to-end study activity. - Participate in In-House Study team meetings as appropriate. - Utilize tools to track activities and develop reports. - Conduct Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Feasibility Questionnaires. - Conduct site contract/budget negotiations (Confidentiality Agreements, Clinical Trial Agreements and Ancillary Agreements). - Collect essential documents and track, review quality & upload into systems. - Support the collection of country and site level intelligence. - Support and complete Ethics Committee and 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. - Bring sites to Regulatory GreenLight and ensure site fulfillment of all maintenance activities. Your Profile: - BA/BS degree in Science or related field. - At least 5 years’ experience in site start-up and contract management in pharmaceutical company or in clinical research organization. - Thorough knowledge of applicable regulations, drug development, and clinical trial management procedures. - 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. - Proficient in English and local languages as needed. - Excellent planning and organizational skills with effective time management. - Excellent interpersonal 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 clinical research principles and process. - Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and country/local regulatory requirements- as applicable. - Goal oriented, self-starter with proven ability to work independently; - Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines; - Comfort with ambiguity; ability to act without having the total picture. - Ability to proactively identify and solve problems. #LI-JS1 #LI-Remote 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 maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. 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. 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 or submit a request here 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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