Senior Clinical Trial Transparency Associate
IN
PRA Health Sciences
Req #: 118314
Type: India
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Overview: As a Senior Clinical Transparency Lead you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities: What you will be doing: * Assesses requirements for clinical trial registration / disclosure of results or public disclosure strategy plans. * Prioritizes, oversees, and performs the day-to-day operations of Clinical Transparency or Public Disclosure, ensuring the timely completion, review and approval of registration, updates and results disclosure activities. * Manages the review and approval process for clinical trial registrations or public disclosure tracking mechanisms, including communication with partner companies or collaborators. * Facilitates periodic review of active registrations or public disclosure strategy plans to ensure records are updated or verified as required. * Uses independent judgment to assess clinical transparency or public disclosure activities and problem solving to determine escalation of issues to management. * Coordinates and oversees the work of consultants and vendors as applicable. * Addresses inquiries related to clinical transparency or public disclosure activities. * Provides feedback to Clinical Transparency or Public Disclosure leadership resulting from new and updated transparency requirements. * Leads retrospective review to ensure compliance of trials resulting from new clinical transparency or public disclosure knowledge or requirements. * Develops training materials, reference documents and tools for use with clinical transparency or public disclosure activities. * Educates study or asset team members and other organizational contacts on clinical transparency or public disclosure policies and processes. * Establishes and maintains global working relationships. * Communicate changes throughout the client organization. * Work cross-functionally to improve processes and address changes. * Evaluate process automation, systems, and tools to improve efficiency, accuracy, and productivity. * Lead clinical transparency or public disclosure training for global colleagues. Qualifications: You are: * Bachelor's Degree, or equivalent experience required. * 5 years pharmaceutical industry experience required with experience in Transparency and/or Disclosure activities * Working knowledge of clinical drug development and clinical trial protocols * Excellent organizational skills and high attention to detail. * Self-directed and motivated, with ability to work without significant direct supervision, asking questions when necessary. * Ability to manage multiple tasks and readily switch activities to accommodate priority needs. * Proficient computer skills, including experience with MSWord and Excel. * Healthcare professional background preferred. 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. 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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