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 in KSA to oversee clinical study deliverables at the country level. The role involves ensuring compliance with ICH-GCP, coordinating site monitoring, and managing study timelines.
Key Skills for This Role
Responsibilities
- Oversee assigned study commitments within the country and ensure timely delivery of data to required quality
- Lead activities related to setting up studies locally, assist in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies
- Support study performance at country level ensuring compliance with AZ Procedural Documents, ICH GCP and local regulations
- Coordinate the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits
- Ensure timely submission of application/documents to EC/IRB at start up and for the duration of the study
- Ensure timely readiness of country level Master Informed Consent Form (MICF) and subsequent site level ICFs
- Ensure all country and site level trial essential documents required by ICH GCP prior to study start have been collected and verified
- Plan and coordinate applicable local drug activities
- Support the set up of CTMS at study country level as well as local websites
- Oversee, manage, and coordinate monitoring activities from site activation through to study closure
- Complete monitoring visit reports as required
- Organise regular Local Study Team meetings
Requirements
- Bachelor’s degree in related discipline, preferably Medical, Pharmacy or Health related
- Minimum 2 years of experience working in evidence generation or other related fields (Medical Affairs led studies)
- Good knowledge of international guidelines ICH GCP as well as relevant local regulations
- Proven ability to lead and motivate cross functional teams to deliver clinical trials
- Excellent team building and interpersonal skills
- Excellent organisational skills
- Excellent verbal and written communication skills
- Excellent ability to prioritize and handle multiple tasks
- Excellent attention to details
- Excellent knowledge of spoken and written English
- Good negotiation skills
- Good ability to learn and to adapt to work with IT systems
Full Job Posting
About AstraZeneca
- AstraZeneca is a global, science led, patient focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases.
Site Description
- AstraZeneca is experiencing a significant transformation in the Kingdom of Saudi Arabia, driven by a commitment to advancing healthcare, innovation, and sustainable growth.
Role Summary
- 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.
- 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.
- Preparation and conducting of Investigator Meetings, manage the process of creation, approval all essential documents developed or local customized ICF, Patients Material.
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 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)
Essential Capabilities
- Bachelor’s degree in related discipline, preferably Medical, Pharmacy or Health related.
- Minimum 2 years of experience working in evidence generation or other related fields (Medical Affairs led studies).
- Good knowledge of international guidelines ICH GCP as well as relevant local regulations.
- Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
- Excellent team building and interpersonal skills.
- Excellent organisational skills.
- Excellent verbal and written communication skills.
- Excellent ability to prioritize and handle multiple tasks.
- Excellent attention to details.
- Excellent knowledge of spoken and written English.
- Good negotiation skills.
- Good ability to learn and to adapt to work with IT systems.
Desirable Capabilities
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
- Good knowledge of the Drug Development Process.
- Excellent understanding of the Clinical Study Process including monitoring.
- Very good understanding of the Study Drug Handling Process and the Data Management Process.
- Integrity and high ethical standards.
- Good analytical skills.
- Good resource management skills.
- Good decision making and delegation skills.
- Good financial management skills.
- Basic change management skills.
- Basic coaching skills.
- Basic ability in handling crisis situations.
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.
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