Medical Evidence Generation Associate - KSA
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Key skills for this role
About the Role
AstraZeneca seeks a Medical Evidence Generation Associate in Riyadh to oversee clinical study deliverables, ensure compliance with ICH-GCP, and coordinate site monitoring. Requires a Bachelor's in a health-related field and 2+ years of evidence generation experience.
Key Skills for This Role
Responsibilities
- Oversee assigned study deliverables at country level to deliver committed components according to agreed resources, budget, and timelines
- Ensure compliance of clinical research process with ICH GCP practices, study protocol, AZ Global and Local Clinical SOPs, and regulatory authorities
- Perform site monitoring as needed to support capacity model and ensure sites are identified, qualified, set up, initiated, monitored, closed and documented
- Ensure timely submissions of proper application/documents to Ethics Committee/Regulatory Authority
- Coordinate site selection process by identifying potential sites/investigators and performing Site Quality Risk Assessment
- Contribute to patient recruitment strategy and manage risk
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 organizational skills
- Excellent verbal and written communication skills
- Excellent knowledge of spoken and written English
- Ability to travel nationally and internationally as required
Full Job Posting
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, 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.
- Creating and implementing alternative action plans proactively in order to reach the targeted patient numbers.
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.
- Ensures all country and site level trial essential documents required by ICH GCP prior to study start have been collected and verified for correctness.
- 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 for the role
- 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.
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