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Medical Evidence Generation Associate - KSA

AstraZeneca
Riyadh, KSA
Mid
Onsite
4 weeks ago
Clinical study managementICH GCPSite monitoringRegulatory submissionsEthics Committee submissionsInformed consent form development
Free

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Clinical study managementICH GCPSite monitoring
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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 compliance with ICH GCP, protocol, AZ Global and Local Clinical SOPs, and regulatory authorities and ECs Regulations.
  • Perform site monitoring as needed to support capacity model and ensure sites are identified, qualified, 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 creation and approval of essential documents.
  • Creating and implementing alternative action plans proactively to reach targeted patient numbers.

What you’ll do

  • Has overall responsibility for 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 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.
  • 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.
  • Ensures all country and site level trial essential documents required by ICH GCP prior to study start have been collected and verified.
  • Plans and coordinates applicable local drug activities.
  • Support the set up of CTMS at study country level as well as local websites as required.
  • Oversees, manages, and coordinates monitoring activities from site activation through to study closure.
  • Complete monitoring visit reports.

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.

Why AstraZeneca?

  • At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit.
  • An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development.
  • We’re on an exciting journey to pioneer the future of healthcare.

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