Warsaw, Poland
1 day ago
Specialist, Global Clinical Solutions - IRT
Specialist, Global Clinical Solutions

Clinical Operations within Global Medicines Development (GMD) is accountable for the delivery of clinical studies.

Global Clinical Solutions (GCS) drives the delivery of Business Process Excellence and Technology for organisation, owning and providing industry leading process, technology and services on behalf of Clinical Operations and its internal and external Partnerships.  

  

The GCS Specialist is a member of the Global Clinical Solutions Team, and is Actively support Clinical Operations by ensuring the population and availability of complete, high quality data from Clinical Operations processes and systems. Deliver Clinical Operations processes and systems trainings and participate in the coordination of the life cycle management of processes and systems/tools including associated documentation (procedural, system). Deliver global centralized services across drug projects and/or other activities that enable delivery of Clinical Development programs to time, cost, and quality across all delivery models.

Individuals in this job may be assigned one or more roles relating to the development and maintenance of Enablement processes, systems and services owned by GMD Clinical Operations.

Operational Activities

As the member of a specific activity team :

Delivers GCS services across drug projectsSets up and maintains systems/tools and data associated with Clinical Operations enabling services in partnership with Study Teams and external partners to appropriate standards, completeness, quality and consistencySupports life cycle management and business continuity for Clinical Operations processes, systems/tools, standards, procedural documentation and training materials,Provides support to user communities includingconducting relevant process/system/tool trainingsfacilitating knowledge sharingestablishing of best practiceensuring communication within Clinical OperationsPerforming validation and testing of processes and systemsPerforms analyses of Clinical Operations processes and tools to define business usage and identify opportunities to improve efficiency/effectiveness of systems/methods/processes; Support in User Requirement Specifications and User Acceptance TestsContributes to business cases for continuous improvement projectParticipates in change initiatives relating to Clinical Operations.

Essential

Bachelor’s degree or other equal education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customersProven organizational and analytical skillsProven ability to multitasking, time management and have task oriented performancePrevious administrative training/experienceComputer proficiencyExcellent knowledge of spoken and written EnglishStrong communication skillsExhibit of AZ Values and Behaviors.

Desirable

University degree in biological science or health care related fieldA good understanding of the clinical study processWork experience in the pharmaceutical industry or in the environment of clinical study delivery/clinical development processesKnowledge of pharmaceutical drug development and clinical study processes and associated government regulations, ICH GCP.Shown willingness and ability to train others on study support processes and proceduresDemonstrate the ability to proactively identify risks and issues as well as possible solutionsGxP trained

Date Posted

09-Jan-2025

Closing Date

22-Jan-2025

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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