Medical Evidence Generation Associate - KSA📣 Job Ad
in Astrazeneca
about 4 hours ago
about 4 hours agoShare
 | Contract Type | Full-time |
 | Workplace type | On-site |
 | Location | Riyadh |
About the Role
AstraZeneca is undergoing a significant transformation in Saudi Arabia, driven by a commitment to healthcare advancement, innovation, and sustainable growth. As part of this evolution, we are seeking a Medical Evidence Generation Associate to join our high-performing team in Riyadh. This role is pivotal in ensuring the successful execution of clinical studies, contributing to our mission to discover, develop, and commercialize medicines for some of the world's most challenging diseases. You will be empowered to cut through the noise and make a real difference, leveraging our agility and scientific focus to uncover opportunities and move into new areas. This position offers an opportunity to be part of a dynamic environment that demands visionary and agile professionals, driven to shape the future of healthcare in Saudi Arabia. You will play a key role in delivering the committed components for clinical studies in compliance with agreed resources, budget, and timelines, while upholding the highest ethical standards and contributing to the ambitious goals outlined in Saudi Vision 2030.
Key Tasks and Responsibilities
- Oversee assigned country-level studies to deliver committed components in accordance with agreed resources, budget, and timelines.
- Ensure clinical research process compliance with ICH-GCP, study protocol, AZ global and local clinical SOPs, regulatory authorities and Ethics Committees (ECs) regulations, while staying updated on any changes.
- Participate in system/process improvement projects within local working teams.
- Conduct site monitoring as needed to support the capability model and ensure site identification, qualification, initiation, monitoring, and closure, with documentation archiving.
- Ensure timely submission of applications and relevant documentation to the Ethics Committee/Regulatory Authority.
- Maintain close communication with the Clinical Research Lead/Head and local, regional, and global study teams, taking full responsibility for study commitments and timely data delivery with the required quality.
- Prepare and conduct investigator meetings.
- Manage the creation and approval of all essential documents, including country-specific informed consent forms and patient materials, ensuring distribution of approved final versions.
- Proactively develop and implement contingency action plans to meet target patient numbers, monitor patient recruitment in coordination with investigators, and take necessary precautions.
- Lead activities related to local study start-up and assist in forecasting study timelines, resources, recruitment, budget, study materials, and drug supplies.
- Ensure feasibility assessments for potential studies are conducted with the highest quality.
- Coordinate the site selection process by identifying potential sites/investigators, conducting initial site quality risk assessments, and holding site qualification visits.
- Ensure timely readiness of the country-level Master Informed Consent Form (MICF) and subsequent site-level informed consent forms, including translations, in line with AZ SOPs and local regulations.
- Verify the collection and accuracy of all country and site-level essential trial documents required by ICH-GCP prior to study start.
- Plan and coordinate local drug activities applicable to relevant studies.
- Support the setup of the Clinical Trial Management System (CTMS) at the study country level and local sites as mandated by local laws and regulations.
- Oversee the management and coordination of monitoring activities from site activation to study closure at country and site level according to monitoring plans.
- Complete monitoring visit reports as appropriate and in accordance with AZ SOPs.
- Organize regular local study team meetings based on a defined agenda.
- Actively work on establishing good interpersonal relationships with all study team members and site staff.
- Report study progress and updates to the Head of Evidence Generation.
- Contribute to patient recruitment strategies, including regular communication with participating investigators.
- Proactively participate in identifying risks and facilitating the resolution of complex study issues and problems, maintaining and reviewing risk management plans at the country study level.
- Ensure the preparation and update of relevant systems and organize their access at the country level.
- Ensure accurate study-related payments are made in accordance with local regulations and agreements.
- Participate in the training and mentoring of new members of the Medical Evidence Generation team.
- Ensure essential document completion to maintain "Ready for Screening" status in the electronic Trial Master File (eTMF) system.
- Ensure all study documents are ready for final archiving and completion of the local part of the eTMF system.
- Plan and lead activities related to audits and regulatory inspections in collaboration with the Head of Medical Evidence Generation.
- Provide input for process development and improvement.
- Provide regular updates to the Head of Evidence Generation on study performance, planned milestones, key issues, and research observations.
- Collaborate with cross-functional teams including Medical Affairs, Market Access, Regulatory, Procurement, Safety, Legal, and Compliance.
- Maintain the highest ethical standards and operate in the spirit of the AstraZeneca Code of Conduct, adhering to company policies.
- Ensure all activities undertaken are compliant with local legislation and corporate standards.
- Timely reporting of Health/Environment/Well-being incidents, adverse events, and changes in conflict of interest status.
Qualifications and Requirements
- Bachelor's degree in a relevant discipline, preferably in a medical, pharmaceutical, or health-related field.
- Minimum of 2 years of experience in evidence generation or related fields (Medical Affairs-led studies).
- Good knowledge of ICH-GCP guidelines and relevant local regulations.
- Proven ability to lead and motivate cross-functional teams to deliver clinical trials on or ahead of plan, within budget, and to the required quality.
- Ability to travel nationally and internationally as required.
Required Skills
- Experience in ICH-GCP practices and clinical study protocols.
- Proficiency in AZ global and local clinical SOPs.
- Understanding of regulatory authorities and Ethics Committees regulations.
- Experience in site monitoring and site qualification.
- Skill in submitting applications to the Ethics Committee/Regulatory Authority.
- Experience in organizing and conducting investigator meetings.
- Proficiency in managing Informed Consent Forms (ICFs).
- Ability to develop and implement patient recruitment strategies.
- Experience in developing and managing risk management plans.
- Knowledge of electronic Trial Master File (eTMF) systems.
- Experience in preparing for audits and regulatory inspections.
- Proficiency in process development and improvement.
- Strong cross-functional collaboration skills.
- Excellent team building and interpersonal skills.
- Excellent organizational skills.
- Excellent verbal and written communication skills.
- Exceptional ability to prioritize and handle multiple tasks.
- Excellent attention to detail.
- Excellent knowledge of spoken and written English.
- Good negotiation skills.
- Good ability to learn and adapt to IT systems.
- Good medical knowledge and ability to learn AZ relevant 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 data management process.
- High integrity and ethical standards.
- Good analytical skills.
- Good resource management skills.
- Good decision-making and delegation skills.
- Good financial management skills.
- Basic change management skills.
- Basic mentoring skills.
- Basic crisis management ability.
- Good cultural awareness.
Work Environment and Location
This is a full-time position requiring national and international travel as needed. Applications from within Saudi Arabia only will be considered. AstraZeneca is committed to fostering diversity and equal opportunities, and aims to build an inclusive and diverse team that represents all backgrounds and promotes diverse perspectives. We welcome all qualified candidates regardless of their characteristics and are committed to all applicable laws and regulations regarding non-discrimination in employment and work eligibility verification.
Requirements
- Requires 2-5 Years experience
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