Medical Evidence Generation Associate - Gulf
دوام كامل
في AstraZeneca GmbH
في
UAE
نُشرت يوم December 22, 2024
تفاصيل الوظيفة
JOB TITLE Medical Evidence Generation Associate - Gulf 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. 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.
- Preparation and conducting of Investigator Meetings, manage the process of creation, approval of 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; monitoring the patient admission processes in coordination with the researchers.
- 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.
- Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits.
- 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.
- 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.
- Oversees, manages, and coordinates monitoring activities from site activation through to study closure.
- Organises regular Local Study Team meetings on an agenda driven basis.
- Reports study progress/update to the Evidence Generation Head.
- Collaborates with cross functional teams including but not limited to, Medical Affairs, Access, Regulatory & Procurement, Safety, legal & Compliance.
- Maintains highest ethical standards and work in a spirit of AstraZeneca Code of Ethics.
- Ensures that all conducted activities are done in accordance with local legislation and corporate standards.
- 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.
- Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
- Proven ability to lead and motivate cross-functional teams.
- 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.
- Good negotiation skills.
- Ability to travel nationally and internationally as required.
- Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
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