Medical Evidence Generation Associate - KSA
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Key skills for this role
About the Role
AstraZeneca is seeking a Medical Evidence Generation Associate for KSA to oversee clinical study deliverables, ensure compliance with ICH-GCP and regulations, and manage site monitoring and study setup.
Key Skills for This Role
Responsibilities
- Oversee assigned studies at country level, ensuring delivery of committed components according to resources, budget, and timelines
- Ensure compliance with ICH GCP, study protocol, AZ SOPs, and regulatory authorities
- Perform site monitoring as needed, including site identification, qualification, setup, initiation, monitoring, and closure
- Coordinate timely submissions to Ethics Committee/Regulatory Authority
- Prepare and conduct Investigator Meetings
- Manage essential documents including ICF and patient materials
- Contribute to patient recruitment strategy and risk management
Requirements
- Experience in clinical research and study management
- Knowledge of ICH GCP practices and local regulations
- Ability to perform site monitoring and quality assessments
- Strong communication and team collaboration skills
- Only applications in KSA will be considered
Full Job Posting
Role Overview
- 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 Cli
Key Responsibilities
- 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 study 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)
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.
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