AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases.
But we're more than one of the world's leading pharmaceutical companies.
At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration.
Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
**Main responsabilities**:
- Direct study start-up, execution, close-out activities and reporting issues;
- Supervise collect, review and track regulatory and other relevant documents;
- Lead the set-up of the electronic Trial Master File (eTMF) including tracking of documents.
Maintain and close the eTMF ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance;
- Lead the production of study documents, ensuring template and version compliance;
- Create and/or import clinical-regulatory documents into ANGEL according to relevant processes and maintain documents according to current process ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in ANGEL;
Plan the administrative appendices for the CSR;
- Interface with Data Management Centre and/or Data Management Enablement representatives to facilitate the delivery of study related documents;
- Provide input into non-drug project work including training activities and development of procedures as needed;
- Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g.
IMPACT, ESSROS, MEOR Dashboard, and SharePoint) and support others in the usage of these systems;
- Manage and contribute to coordination and tracking of study materials and equipment;
- Coordinate administrative tasks during the study process, governance, audits and regulatory inspections, according to company policies and SOPs;
- Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g.
study team meetings, monitor meetings, Investigator meetings, MEORT meetings.
Liase with internal and external participants and/or vendors;
- Prepare, contribute and distribute presentation material for meetings, newsletters and web-sites;
- Oversight of all ESR and EAP process as a ESR coordinator;
- Identify new and current ESR/EAP that requires actions from LREG or GREG;
- Track the progress of ESR/EAP that are on MC side ensuring timelines are held;
- Oversight of regulatory and administrative ESR/EAP process;
- Control and Provide Finance reports to key stakeholders;
- Ad hoc actions on behalf of MEOR Manager Leadership;
- Responsibility for GXP areas to ensure the legal and regulatory requirements of evidence generation roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improvement.
**Essential Skills**:
- Bachelor´s degree.
- Experience from Clinical Operational Activities (regulatory, start up and clinical monitoring tasks);
- Leadership behaviour;
- Computer proficiency on CTMS System, MS Project and Excel;
- Proficiency spoken and written English;
- GCP/ICH and Local regulation knowledge required.