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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Initiation Clinical Research Associate - FSP
Job ID R0000030265 , ArgentinaParexel FSP is hiring two Senior Initiation Clinical Research Associates. Candidates could be based in Mexico, Argentina or Brazil. The position will be remote.
The Senior Initiation Clinical Research Associate will be responsible for ensuring the completeness of Site Essential Document Packages as well as the Site Regulatory Packages (SRP) required to achieve site initiation and activation status. This also includes the renewal of critical essential documents in the event of protocol amendments introduced during the Final Approved Protocol to Last Patient, First Visit. Areas of additional responsibility include the tracking of document translations requirements, site SRP reviews and approvals, and required training activities.
Will ensure the clinical study insurance documents are current and filed in the electronic Trial Master File (TMF) from the beginning of the study until study completion in compliance with SOPs and guidance.
Introduces specialized industry-leading and/or emerging concepts to develop innovative business solutions. Serves as an advisor, mentor, internal consultant, and/or helps drive new initiatives
Additionally, may be responsible for planning and delivery of European Union Clinical Trials Directive/Regulation (EUCTD/R) reporting according to the Part II requirements outlined by the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS). Coordination with Regulatory Affairs, Clinical Trial Management and Clinical Transparency will be core to the role.
Additionally, may serve as the primary contact for acquiring insurance documents on behalf of the clinical study team. May serve as the main liaison between the sponsor/CRO and the insurance broker/carrier. The Associate Manager Clinical Documentation – May ensure the clinical study insurance documents are current and filed in the electronic Trial Master File (TMF) from the beginning of the study until study completion in compliance with SOPs and guidance.
Required experience:
A bachelor's degree and 3 years in essential or regulatory document management in Pharmaceutical /CRO industry, understanding of clinical study start up requirements and working knowledge of relevant documentation.
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