Clinical Study Administrator for BioPharma Department

The Clinical Study Administrator (CSA) supports the coordination and administration of interventional clinical studies from start-up through execution to close-out within the Local Study Team (LST). The role ensures quality, consistency, and inspection readiness of study deliverables to meet time, cost, and quality objectives, acting as a central administrative contact and maintaining critical study documentation and systems in compliance with ICH-GCP and local requirements.

Typical Accountabilities
• Study coordination: Assists with study activities from start-up to close-out, coordinating administrative tasks, audits, and inspections per SOPs and policies.
• Regulatory/ethics documentation: Collects, prepares, reviews, tracks, and submits documents to EC/IRB and, where applicable, Regulatory Authorities; interfaces with investigators, vendors, and CRAs to ensure effective document delivery.
• eTMF/ISF management: Sets up, maintains, and tracks documents in the local eTMF and ISF to ensure Inspection Readiness; supports CRA with ISF close-out and ensures final archiving.
• Document production and compliance: Produces and maintains study documents with template/version control; creates/imports clinical-regulatory documents into global systems (e.g., ANGEL) per the AstraZeneca Authoring Guide.
• Submission readiness: Handles clinical-regulatory documents per Submission Ready Standards (SRS) to support electronic publishing and delivery to authorities.
• Systems and tracking: Sets up, populates, and maintains CTMS (e.g., VCV), SharePoint, and other tracking/communication tools; supports user adoption where applicable.
• Site contracts and payments: Prepares/supports site-level contracts and manages HCO/HCP payments in line with local regulations (where not covered by dedicated roles).
• Materials and logistics: Coordinates and tracks study materials and equipment; manages practical arrangements for internal/external meetings (study team, monitors, investigators) and liaises with participants/vendors per codes.
• Communications and archiving: Prepares/distributes presentations, newsletters, website content; manages layout/language control, printing,distribution, and archiving of study/country emails; supports local translation and English spell checks. • Data management interface: Interfaces with Data Management Centre and Global Clinical Solutions to facilitate delivery of study-related documents/materials.
• Compliance: Ensures adherence to AstraZeneca’s Code of Ethics, policies (people, finance, technology, security, SHE), and all applicable local/national/regional legislation.

Qualification
• Education: High/Secondary school qualification (*) supporting effective interactions and responsibilities.
• Experience: Administrative experience, preferably in medical/life sciences.
• Clinical process knowledge: Working knowledge of the Clinical Study Process and understanding of ICH-GCP and related procedures.
• Technical skills: Computer proficiency with ability to develop advanced skills to improve task efficiency; familiarity with study systems and document management.
• Organizational skills: Proven organizational and administrative capabilities.
• Interpersonal skills: Strong teamwork and communication, able to work in an international environment.
• Language: Good spoken and written English

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.