Medical Evidence Generation Associate - KSA

Assigned Studies oversight of deliverables at country 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 Perform 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. Ensuring 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 all essential documents developed or local customized ICF, Patients Material, responsible for distribution within the team of final approved version of all essential documents (Protocol, ICF, etc.). Creating and implementing alternative action plans proactively in order to reach the targeted patient numbers; monitoring the patience admission processes in coordination with the researchers; planning and taking the necessary precaution when required

What you ll do

Has the overall responsibility for the assigned study commitments within the country and for timely delivery of data to required quality.

Lead on activities related to setting up studies (local), assist in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.

Team player to support stud performance at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations.

Ensures, 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 enrol, and in line with AZ SOPs.

Plans and coordinates applicable local drug activities (for applicable studies) Support the sets up of CTMS at study country level as well as local websites as required by local laws and regulations.

Oversees, manages, and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.

Complete monitoring visit reports (as required and following AZ SOPs) Organises regular Local Study Team meetings on an agenda driven basis.

Actively works towards achieving good personal relationships with all Study Team members, sites staff.

Reports study progress/update to the Evidence Generation Head.

Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.

Proactively share identifies risks and facilitates resolution of complex study problems and issues to support the Development, maintains and reviews of risk management plan on country study level proactively manages sites, stakeholders to ensure risks are timely identified, mitigated, and managed.

Ensures relevant systems required are set-up, updated and access is organised at country level.

Ensures accurate payments related to the study are performed according to local regulations and agreements.

Participates in training and coaching new members of the Medical Evidence Team ensuring compliance with ICH-GCP and AZ Procedural Documents.

Ensures completeness of essential documents are ready in a timeline manner to maintain the eTMF Inspection Ready .

Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.

Plans and leads activities associated with audits and regulatory inspections in liaison with Medical Evidence Generation Head.

Provides input to process development and improvement.

Provides regular information to Evidence Generation Head country level on study/ies and planned study milestones/key issues and updates about the study performance and feedback on any research related information.

Collaborates with cross functional teams including but not limited to, Medical Affairs, Access, Regulatory & Procurement, Safety, legal & Compliance.

Corporate responsibility: Maintains highest ethical standards and work in a spirit of AstraZeneca Code of Ethics, following rules & norms set by corporate policies.

Ensures that all conducted activities are done in accordance with local legislation and corporate standards.

Timely reports (as per respective procedures): health/environment/wellbeing related accidents; adverse events that you became aware about; change in status of your Conflict of Interest.

Only applications in KSA will be considered.