Local Study Manager
6 days ago
**JOB TITLE**
**Local Study Manager & Quality Associate GCC**
**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. But we’re more than one of the world’s leading pharmaceutical companies.
**ROLE SUMMARY**
The Sales Manager role for Vaccine and Immune will be directly supervising group of speciality brand sales representatives. This role key accountability will be to deliver sales results for entire geography. Position will be based in UAE (Dubai) managing a sales team across the Gulf countries.
**What you’ll do**
**Study Management**
- To lead Local Study deliverables at the 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 SOPs, and the regulatory authorities and ECs Regulations; being knowledgeable about these procedures and keeping abreast of any changes and revisions, participating in system/process improvement projects within local task groups consisting of employees from different units
- Perform site monitoring as needed to support the capacity model and to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed, and documentation archived.
- Preparation and conducting of Investigator Meetings, manage the process of creation, approval of all essential documents developed or local customized ICF, Patients Material, responsible for distribution within the team of the final approved version of all essential documents (Protocol, ICF, etc.).
- 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; planning and taking the necessary precaution when required
**Quality**
- Conduct clinical research activities and interactions as per AstraZeneca values and in compliance with the Code of Conduct and GCP global & local policies
- Complete on time all required GCP trainings through different AZ training platforms.
- Report potential issues of non-compliance related to Clinical Research and ongoing studies.
- Identifies GCP quality Issues, analyses root causes and set CAPA (Corrective Actions & Preventive Actions) on VQV system to be implemented.
- Understand & comply with legal and local MOH legislations & implement regulatory requirements related to GCP.
- Ensure GCP local & global SOPs are followed by local Investigators & other CR stakeholders.
- Support Audit & Inspections with relevant GCP documents.
- Archiving & retrieving GCP documents.
- Deliver regular training to Clinical Research stakeholders on GCP to ensure compliance.
- Monitor Clinical research activities that are managed by local CRO (Clinical Research Organization) to ensure the activities are compliant with AZ SOPs & compliant with local MOH quality requirements.
- Identifying GCP risks and preparing a plan of actions to mitigate the risks.
- 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 and regional), selecting CROs, assist in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
- Team player to support stud 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 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)
- Performs co-monitoring, Accompanied Site Visits/training
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