AstraZeneca Hiring for Local Study Manager & Quality Associate – GCC Job at Dubai Full Time

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 commercialization 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.

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.
• Ensuring timely submissions of proper application/documents to Ethics 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 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 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, 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 visits as applicable.
• Organises regular Local Study Team meetings on an agenda driven basis.
• Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff
• Reports study progress/update to the Evidence Generation Head
• Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
• Proactively share identifies risks and facilitates resolution of complex study problems and issues to support the Development, maintains and reviews of risk management plan on country study level proactively manages sites, stakeholders to ensure risks are timely identified, mitigated, and managed.
• Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
• Plans and leads National Investigator meetings, in line with local codes, as required.
• Ensures relevant systems required are set-up, updated and access is organised at country level.
• Ensures accurate payments related to the study are performed according to local regulations and agreements.
• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and AZ Procedural Documents.
• Ensures completeness of essential documents are ready in a timeline manner to maintain the eTMF “Inspection Ready”.
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
• Plans and leads activities associated with audits and regulatory inspections in liaison with Clinical Research Lead/Head.
• Provides input to process development and improvement.
• Provides regular information to Evidence Generation Head country level on study/ies and planned study milestones/key issues and updates about the study performance and feedback on any research related information
• Collaborates with local Medical Affairs team.

Corporate responsibility:

• Maintains highest ethical standards and work in a spirit of AstraZeneca Code of Ethics, following rules & norms set by corporate policies
• Ensures that all conducted activities are done in accordance with local legislation and corporate standards.
• Timely reports (as per respective procedures): health/environment/wellbeing related accidents; adverse events that you became aware about; change in status of your Conflict of Interest.

Essential for the role

• Bachelor’s degree in a related discipline, preferably Medical, Pharmacy or Health related.
• Minimum 5 years of experience working in local study start up, development Operations (CRA, Sr CRA) or other related fields (Medical Affairs-led or Academic-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 project management skills.
• 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.
• Ability to travel nationally and internationally as required.

Desirable for the role

• 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.
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• 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.
• Good intercultural awareness.

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. There’s no better place to make a difference to medicine, patients, and society. 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.

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

Where can I find out more?

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