Clinical Study Administrator (Biopharma)

At AstraZeneca, we unlock the power of what science can do. Empowered to explore, everyday we work towards our ultimate aim – treating, preventing, modifying and even curing complex diseases. With an unwavering belief in following the science, we unleash our curiosity. Investing in key areas, harnessing innovative technologies and taking smart risks. Help to shape the future of healthcare as we take our pipeline from strength to strength. Embrace an environment built on lifelong learning. Never complacent, we seek opportunities to expand our knowledge. The place to build a long-term meaningful career. Here we get to develop and grow – whether that’s working at the leading-edge or on varied stages and molecules. Working on things that have never been done before. In return, when great science comes alive, we have the opportunity to get published. We stand together behind a shared ambition. United by our collective passion for having a positive impact on patients’ lives. Important work that is both meaningful and fulfilling. With the potential to reach over a billion patients across the globe who are living with these complex diseases.

Background & Qualifications ​

• University and master's degree, preferably from Healthcare related areas (Pharmacy, Veterinary, Chemistry, Biology, Medical etc. Faculties),
• Good knowledge of spoken and written English
• Previous administrative experience preferably in the medical/ life science field is an advantage
• Strong communication and negotiation skills,
• Ability to prioritize and handle multiple tasks,
• Effective planning and organizational skills with a result-oriented approach,
• Analytical thinking, critical reasoning ability,
• Good command of MS Office applications,
• No military obligation for male candidates.

Job Description

• Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
• Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
• Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
• Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
• Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.
• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
• Contributes to the production and maintenance of study documents, ensuring template and version compliance.
• Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g. ANGEL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents.
• Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.
• Sets-up, populates and accurately maintains information in AstraZeneca tracking and communication tools (e.g. CTMS such as VCV, SharePoint, etc) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems).
• Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts).
• Prepares/supports/performs Health Care Organizations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.
• Manages and contributes to coordination and tracking of study materials and equipment.
• Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.
• Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g., study team meetings, Monitors’ meetings, Investigators’ meetings. Liaises with internal and external participants and/or vendors, in line with international and local codes.
• Prepares, contributes to and distributes presentation material for meetings, newsletters and web-sites.
• Responsible for layout and language control, copying and distribution of documents. Supports with local translation and spell checks in English to/from local language, as required.
• Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related e-mails.
• Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material.
• Ensures compliance with AstraZeneca’s Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• Ensures compliance with local, national and regional legislation, as applicable.

Why AstraZeneca?

A high performing team, we work hard to not just meet but go beyond the needs of patients and the wider healthcare industry We leverage our partnerships with external experts across the industry, to create and communicate evidence that changes medical practice. As a partner for many, we effectively communicate complex ideas whilst seeking to understand ever-changing needs and requirements. Our valuable contribution and scientific expertise is responsible for advancing our pipeline and accelerating our pathway to finding a cure. Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazenecaturkiyekariyer/

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.