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You will act as the main local administrative contact and work closely with CRAs and/or LSAD for the duration of assigned studies.</p>\n<p><strong>Key Responsibilities</strong></p>\n<ul>\n<li>Coordinate administrative tasks during the study process, audits and regulatory inspections in line with company policies and SOPs.</li>\n<li>Support the collection, preparation, review and tracking of documents required for the application process.</li>\n<li>Support the Study Start-up team with timely submissions to Ethics Committees/Institutional Review Boards (EC/IRB) and, where applicable, Regulatory Authorities.</li>\n<li>Take operational responsibility for correct set-up and ongoing maintenance of the local electronic Trial Master File (eTMF) and Investigator Study File (ISF), ensuring document tracking in accordance with ICH-GCP and local requirements to maintain inspection readiness.</li>\n<li>Ensure all study documents are prepared for final archiving and support CRAs with ISF close-out activities.</li>\n<li>Contribute to the production and maintenance of study documents, ensuring compliance with required templates and versions.</li>\n<li>Manage clinical-regulatory documents in the Global Regulatory management system, as required.</li>\n<li>Manage clinical-regulatory documents for electronic applications and submissions, complying with Submission Ready Standards (SRS) to support efficient publishing and delivery to regulatory authorities, where applicable.</li>\n<li>Serve as primary point of contact for legal negotiations related to confidentiality agreements and amendments.</li>\n<li>Process study-level and site-level amendments.</li>\n<li>Prepare and/or support site-level contract preparation, except where a specific local role is assigned.</li>\n<li>Prepare, support and perform payments to Health Care Organisations (HCO) and Health Care Professionals (HCP) in accordance with local regulations.</li>\n<li>Set up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. Clinical Trial Management System [CTMS]) and support others in the use of these systems, except in countries with a designated system administrator.</li>\n<li>Manage and contribute to the coordination and tracking of study materials and equipment.</li>\n<li>Interface with Data Management Centres and/or Global Clinical Solution representatives to support delivery of study-related documents and materials.</li>\n<li>Interface with investigators, external service providers and Clinical Research Associates (CRAs) to facilitate effective document collection and study delivery.</li>\n<li>Lead practical arrangements for internal and external meetings (e.g. study team meetings, monitors&#39; meetings, investigators&#39; meetings), liaising with internal and external participants and vendors in line with applicable international and local codes.</li>\n<li>Prepare, contribute to and distribute material for meetings, newsletters and web content, in alignment with LST and global stakeholders.</li>\n<li>Perform document layout and language checks, as well as copying and distribution.</li>\n<li>Provide support for local translation and English language checks, as required.</li>\n<li>Handle printing and distribution of documents (e.g. letters, meeting minutes) and manage and archive study- and country-related emails.</li>\n<li>Ensure compliance with AstraZeneca&#39;s Code of Ethics, policies and procedures, including those related to people, finance, technology, security and Safety, Health and Environment (SHE).</li>\n<li>Adhere to all relevant local, national and regional legislation.</li>\n<li>Carry out additional country-specific tasks in accordance with local organisational needs, when assigned.</li>\n</ul>\n<p><strong>Requirements</strong></p>\n<ul>\n<li>Bachelor&#39;s degree aligned to the knowledge and skills required for the role.</li>\n<li>0+ years of experience required.</li>\n<li>Relevant knowledge of the drug development process, international guidelines (ICH-GCP) and applicable country regulations.</li>\n<li>Personal effectiveness and strong self-accountability.</li>\n<li>Learning agility.</li>\n<li>Financial, technology and process competency.</li>\n<li>Active listening and fluency in written and spoken business-level English.</li>\n<li>High integrity and ethical standards.</li>\n<li>Ability to work effectively as part of a team in both in-person and virtual settings; 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This role is perfect for someone who&#39;s passionate about the intersection of systems, privacy, and legal compliance. You will architect, design, and write backend systems responsible for handling some of the most sensitive data at OpenAI.</p>\n<p>This role is based in Dublin, Ireland. We use a hybrid work model of 3 days in the office per week and offer relocation assistance to new employees.</p>\n<p><strong>In this role, you will:</strong></p>\n<ul>\n<li>Design, build, and maintain back-end systems and services that power privacy and data compliance functions within our API products and consumer applications.</li>\n</ul>\n<ul>\n<li>Work closely with legal advisors and other engineers to respond to court orders and other legal processes, all while upholding strict data privacy and legal standards.</li>\n</ul>\n<ul>\n<li>Identify opportunities for automation and build the tools that enable other teams to automate tasks involving customer data.</li>\n</ul>\n<ul>\n<li>Develop and implement data handling policies and procedures in compliance with legal and ethical standards, ensuring the integrity and confidentiality of user data.</li>\n</ul>\n<p><strong>You might thrive in this role if you:</strong></p>\n<ul>\n<li>Have experience building data pipelines, especially for legal processes and investigative workflows.</li>\n</ul>\n<ul>\n<li>Can translate legal requirements into technical solutions and explain technical solutions to a non-technical audience.</li>\n</ul>\n<ul>\n<li>Take responsibility for problems from beginning to end, and are prepared to acquire any missing knowledge necessary to get the job done.</li>\n</ul>\n<ul>\n<li>Create tools to speed up your own and your colleagues’ workflows, particularly when pre-existing solutions are inadequate.</li>\n</ul>\n<ul>\n<li>Deeply care about user experience and take pride in developing products that meet customer needs while ensuring privacy.</li>\n</ul>\n<ul>\n<li>Have a background in security investigations or experience working in collaboration with trust and safety, legal, and engineering teams.</li>\n</ul>\n<p><strong>Compensation, Benefits and Perks</strong></p>\n<p>This is a position with OpenAI Ireland Ltd., which controls the hiring and management of this position.</p>\n<p>Total compensation includes an annual salary, generous equity, and benefits.</p>\n<ul>\n<li>Medical, dental, and vision insurance for you and your family</li>\n</ul>\n<ul>\n<li>Mental health and wellness support</li>\n</ul>\n<ul>\n<li>PRSA plan with 6% employer matching</li>\n</ul>\n<ul>\n<li>Unlimited time off</li>\n</ul>\n<ul>\n<li>Annual learning &amp; development stipend (€1,400 per year)</li>\n</ul>\n<p><strong>About OpenAI</strong></p>\n<p>OpenAI is an AI research and deployment company dedicated to ensuring that general-purpose artificial intelligence benefits all of humanity. We push the boundaries of the capabilities of AI systems and seek to safely deploy them to the world through our products. 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