MEOR Study Administrator
Warszawa MEOR Study Administrator
Warszawa
NR REF.: 1098479
Global Medical Affairs (GMA) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AZ therapies and support our internal stakeholders with medical insight and expertise. GMA provides medical leadership with market participation and connectivity while also influencing the life cycle planning and execution of all our products. Global Medical Affairs aims to lead AstraZeneca in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do. Medical Evidence and Observational Research (MEOR) is accountable for the delivery of Global strategic studies required in order to generate the evidence to build the confidence on AZ therapies and additional Observational research, Externally sponsored research and Early Access Program required by Global Product Teams. MEOR Study Administrator participates in the coordination of and contribute to operational activities to ensure quality and consistency of MEOR deliverables to time, cost, and quality objectives from Study Design Concept (SDC) through study close-out activities and Clinical Study Report (CSR). MEOR Study Administrator contributes to the review and operational activities of Externally Sponsored Research (ESR)
Typical responsibilities:
Warszawa
NR REF.: 1098479
Global Medical Affairs (GMA) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AZ therapies and support our internal stakeholders with medical insight and expertise. GMA provides medical leadership with market participation and connectivity while also influencing the life cycle planning and execution of all our products. Global Medical Affairs aims to lead AstraZeneca in achieving scientific leadership, being a great place to work, and keeping patients at the core of everything we do. Medical Evidence and Observational Research (MEOR) is accountable for the delivery of Global strategic studies required in order to generate the evidence to build the confidence on AZ therapies and additional Observational research, Externally sponsored research and Early Access Program required by Global Product Teams. MEOR Study Administrator participates in the coordination of and contribute to operational activities to ensure quality and consistency of MEOR deliverables to time, cost, and quality objectives from Study Design Concept (SDC) through study close-out activities and Clinical Study Report (CSR). MEOR Study Administrator contributes to the review and operational activities of Externally Sponsored Research (ESR)
Typical responsibilities:
- Contribute to study start-up, execution, close-out and reporting
- Collect, review and track regulatory and other relevant documents. Interface with Investigators, Strategic Partners, Site Management & Monitoring and internal staff during the collection process to support effective delivery of a study and its regulatory documents through finalization of the Clinical Study Report
- Initiate and lead the set-up of the electronic Trial Master File including tracking of documents. Maintain and close the eTMF ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance
- Initiate and maintain 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 and proactively collate 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, MEOR meetings. Liase with internal and external participants and/or vendors
- Prepare, contribute to and distribute presentation material for meetings, newsletters and web-sites
- Identify new and current ESRs that requires actions from HQ
- Administrate some parts of the process flow
- Provide Finance reports to key stakeholders
- Track the progress of ESR that are on MC side ensuring timelines are held
- Ad hoc actions on behalf of DDs
- Level of education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers
- Proven organizational and analytical skills
- Previous administrative training/experience
- Computer proficiency
- Excellent knowledge of spoken and written English
- Excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
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