Medical Evidence Generation Manager Pakistan cluster

JOB TITLE

Medical Evidence Manager – Gulf Countries & Pakistan Cluster

Dubai, UAE

At AstraZeneca, we communicate and engage with patients to ensure they have positive experiences with our clinical studies, products and services and we gain valuable insights from patients about their disease journey. Join us and help transform patient care across the region. Become a champion for patient engagement and innovation, making meaningful impact on lives.

• Assigned Studies oversight of deliverables at country/ies level to deliver committed components of the aligned clinical study according to agreed resources, budget, and timelines.
• Ensuring the compliance of the clinical research process with ICH‑GCP practices, the study protocol, AZ Global and Local Clinical SOP’s, and the regulatory authorities and ECs Regulations; being knowledgeable about these procedures and keeping abreast of any changes and revision, participating in system/process improvement projects within local task groups consisting of employees from different units.
• Oversee the CRA performing site monitoring as needed to support capacity model and to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
• Oversee timely submissions of proper application/documents to Ethic Committee/Regulatory Authority, close communication with Clinical research lead/Head and local, regional/global study teams and overall responsibility for study commitments, for timely delivery of data to required quality as agreed.
• Preparation and conducting of Investigator Meetings, manage the process of creation, approval of all essential documents developed or locally customized ICF, Patients Material, responsible for distribution within the team of final approved versions of all essential documents (Protocol, ICF, etc.).
• Creating and implementing alternative action plans proactively in order to reach the targeted patient numbers; monitoring patient admission processes in coordination with the researchers; planning and taking necessary precaution when required.

• Has overall responsibility for the assigned study commitments within the country/ies and for timely delivery of data to required quality.
• Lead on activities related to setting up studies (local and regional), selecting CROs, assisting in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
• Team player to support study performance at country level ensuring compliance with AZ Procedural Documents, ICH‑GCP and local regulations.
• Ensure, as required, that feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.
• Ensures timely readiness of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant AZ SOPs and local regulations.
• Ensures all country and site level trial essential documents required by ICH‑GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with AZ SOPs.
• Plans and coordinates applicable local drug activities (for applicable studies)
• Support the setting up of CTMS at study country level as well as local websites as required by local laws and regulations.
• Oversees and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Oversees the completion of monitoring visit reports (as required and following AZ SOPs)
• Performs co‑monitoring, accompanied Site Visits/training visits as applicable.
• Organizes regular Local Study Team meetings on an agenda driven basis.
• Actively works towards achieving good personal relationships with all Study Team members, sites’…