Especialista de Geração de Evidências
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.
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;
Contribute 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;
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.
Experience from Clinical Operational Activities (regulatory, start up and clinical monitoring tasks);
Computer proficiency on CTMS System, MS Project and Excel;
Proficiency spoken and written English;
GCP/ICH and Local regulation knowledge required.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
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 authorisation and employment eligibility verification requirements.