Performs Local studies (clinical & Real World Evidence studies(RWE) including Post Marketing Surveillance) in accordance with AZ Procedural Documents, international guidelines such as International Conference on Harmonization (ICH) and Good Clinical Practice (GCP), as well as relevant local regulations. Effective management of EAP(Early Access Program), such that the EAP programs meets all AstraZeneca internal and local regulations.

Local studies

•  Performs overall responsibilities to deliver committed components of local studies according to agreed resources, budget and timelines in accordance with AZ Procedural Documents, international guidelines such as ICH and GCP, as well as relevant local regulations.
•  Plans, prepares, follows up PMS, phase IV and RWE studies required by Regulatory authorities.
•  Assists the Contract Research Organization (CRO)/site selection process for conducting local studies
•  Communicates with CROs/investigators regarding the project execution status.
•  Communicates with GPT/global study team regarding proceeding studies
•  Prepares agreements with CROs/institutions/investigators/External service Providers.
•  Monitors the project execution milestones.
•  Prepares and submits regulatory required any documents/ reports within timeline
•  Performs any required co-monitoring & QC visits with study monitor(s)
•  Proactively identifies and facilitates resolution of complex study problems and issues.
•  Plans and leads the investigator meetings, in line with local codes
•  Responsible for forecasting study timelines, resources, recruitment, budget, study materials and drugs.
•  Ensures completeness of the Study Master File
•  Ensures local Serious Adverse Event (SAE) reconciliation takes place.
•  Facilitates translation of documents (ICFs, patient diaries, participation cards, etc) through external providers.
•  Ensures timely submission of proper application/documents to IRB if necessary
•  Sets up and maintains the study in IMPACT at study country level.
•  Ensures accurate payments related to the study are performed.
•  Ensures that all study related documents are filed and archived including sign-off completion of the Study Master File.
•  Leads any activities associated with audits and regulatory inspections if required .
•  Provides regular information to Line Manager and relevant functions on studies and planned study milestones/key issues.
•  Ensures that study activities comply with local policies & code of conduct.
•  Liaises with Local Compliance Officer regarding payments to Investigators to ensure local requirements.
•  Timely prepares and supports to process of registration of applicable studies in country-specific or international websites.
•  Participates in training to ensure compliance with ICH/GCP and AZ Procedural Documents
•  Ensure MC Good Clinical Practice (GCP) for Non-interventional studies involving primary data collection quality management system in line with global policy and guidelines as MC GCP Quality Lead.
• EAP
•  Ensures all applicable EAP local regulations are followed
•  Ensures that work instructions are drafted in accordance with global EAP SOP to cover the local management of EAP
•  Responsible for management of communications and submissions to regulatory authorities in EAP
•  Responsible for handling and reporting all safety information in EAP

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.