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YubHub-native raw fields carry `x-` prefix.","jobs":[{"@context":"https://schema.org","@type":"JobPosting","identifier":{"@type":"PropertyValue","name":"YubHub","value":"job_cf6d98aa-97b"},"title":"Clinical Study Administrator - Contracts and Budgets","description":"<p><strong>Job Description</strong></p>\n<p>We are seeking a Clinical Study Administrator - Contracts and Budgets to join our team at US SM&amp;M. As a Clinical Study Administrator, you will be responsible for the coordination and administration of clinical studies from start-up through execution and close-out. 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; demonstrates cultural awareness.</li>\n<li>Ability to identify and champion more efficient delivery of quality clinical trials with optimised cost and time.</li>\n<li>Ability to travel nationally and internationally, as required.</li>\n<li>Valid driving licence, if required by country of employment.</li>\n<li>Strong communication and teamwork skills, including collaboration, business partnering and impactful site conversations.</li>\n<li>Effective, risk-based thinking, including planning and alignment, problem solving, critical thinking and decision making.</li>\n<li>Clinical study operations (GCP) and quality management, including Good Documentation Practice (GDP).</li>\n</ul>\n<p><strong>How to Apply</strong></p>\n<p>If you are interested in this opportunity, please submit your application through our website.</p>\n<p style=\"margin-top:24px;font-size:13px;color:#666;\">XML job scraping automation by <a href=\"https://yubhub.co\">YubHub</a></p>","url":"https://yubhub.co/jobs/job_cf6d98aa-97b","directApply":true,"hiringOrganization":{"@type":"Organization","name":"US SM&M","sameAs":"https://astrazeneca.eightfold.ai","logo":"https://logos.yubhub.co/astrazeneca.eightfold.ai.png"},"x-apply-url":"https://astrazeneca.eightfold.ai/careers/job/563877689867786","x-work-arrangement":null,"x-experience-level":null,"x-job-type":"full-time","x-salary-range":null,"x-skills-required":["Clinical study operations (GCP)","Quality management","Good Documentation Practice (GDP)","Personal effectiveness","Self-accountability","Learning agility","Financial competence","Technology competence","Process competence","Active listening","Business-level English","High integrity","Ethical standards","Cultural awareness","Risk-based thinking","Planning and alignment","Problem solving","Critical thinking","Decision making"],"x-skills-preferred":[],"datePosted":"2026-04-18T22:12:29.538Z","jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Wilmington, Delaware, United States of America"}},"employmentType":"FULL_TIME","occupationalCategory":"Operations","industry":"Healthcare","skills":"Clinical study operations (GCP), Quality management, Good Documentation Practice (GDP), Personal effectiveness, Self-accountability, Learning agility, Financial competence, Technology competence, Process competence, Active listening, Business-level English, High integrity, Ethical standards, Cultural awareness, Risk-based thinking, Planning and alignment, Problem solving, Critical thinking, Decision making"}]}