Manager, Global Clinical Solutions, DPS/eCOA

Global Clinical Solutions (GCS) drives the delivery of services and technology for AstraZeneca for its internal and external stakeholders eCOA stands for electronic Clinical Outcome Assessment (including ePRO – electronic Patient Reported Outcome) and by definition directly or indirectly measures how patients feel or function and can be used to determine whether or not a drug has been demonstrated to provide a treatment benefit. It measures may provide important patient perspective on the disease and the treatment received; an evaluation that provides clinically important information that is not captured by conventional anti-tumor efficacy data and adverse event reporting. DPS stands for Digital Patient Solutions - DPS encompass the entire digital experience of a patient in a specific research setting or study (can include but not limited to eCOA with integrated sensors, devices and/or wearables, patient engagement, telemedicine, eConsent, geo-fencing). The eCOA and DPS Manager is a member of GCS, Co-Project Manager of the study together with service provider’s Project Manager, and is responsible for the coordination/leading the activities ensuring lifecycle management and business continuity for eCOA and DPS system delivery - activities such as defining, testing and maintaining the AstraZeneca (AZ) eCOA and DPS requirements.The eCOA and DPS Manager work across drug projects to enable delivery of Clinical Development programs to time, cost, and quality across all AZ portfolio. Study & Data Solutions is part of the Global Clinical Solutions team that drives the delivery of Business Process Excellence and Technology for the Clinical Operations organisation, owning and providing industry leading process, technology and services on behalf of Development Operations and its internal and external Partners. Responsibilities: Providing input to eCOA and DPS systems based on CSP, previous practical experience from end users and consultancy with eCOA SME/ Solutions Implementation Lead/Study Management and other relevant members to ensure clinical study needs are properly capture in eCOA and DPS user requirements specification Serving as AZ Project Manager and clinical subject matter expert during eCOA and DPS set up and thoughout eCOA change management process Leading operational aspects of eCOA and DPS system set up process to ensure system is delivered to agreed time, cost, quality and functionality Leading operational aspects of eCOA and DPS system maintenance to ensure the system is at all time reflecting CSP and all system issues are appropriately documented, assessed and addressed; adhere and guide the Team around change control framework Leading operational aspects of eCOA and DPS systems closure to ensure the system is closed when required, with all user access revoke and ensuring appropriate eCOA and DPS data are retrieved and stored Establishing user acceptance testing strategy, including validation documentation creation (test scripts, risk assessment, test plan and report) to ensure all study specific elements for the system has been applied by the supplier according to agreed specification; execution of UAT ensuring completion happens on time and according to process Ensuring eCOA and DPS systems are delivered in compliance with AZ procedures, guidelines, agreed ways of working, standards Ensuring eCOA and DPS documents are up to date and properly uploaded to the electronic Trial Master File (eTMF) Report technical quality issues and follow up with supplier on corrective/ preventive actions Cooperate with supplier on reconciliation of identified technical system issues, if deemed to be discrepancy on IRT side, decide on corrective actions and follow up with the supplier on resolution Monitor and escalate poor eCOA compliance, identify data issues and propose actions to be taken Understand details around eCOA and DPS processes, system and services the study team relies on, their needs and pain points. Uses this knowledge to provide advice and guidance, removes barriers, provides solutions and identifies opportunities for improvement Provides guidance and expertise in the planning and delivery of eCOA and DPS systems validation activities (core system and study specific validation), including production and archiving of all computer system validation documentation and performing user acceptance testing Internal and External Contacts - Some examples of contacts/partners are: Global Study Associate Director and/or Global Study Manager Study Implemetion Lead eCOA & DPS Business Analyst R&D Digital Health eCOA SME (Digital Health COA / Patient Centered Science) Supplier Representatives (Project Managers, Solution Designers) to agree on eCOA functionality, documents, trainings, testing and issue trouble shooting System Owner Candidate profile: University degree in related discipline, preferably in computer science, biological science or healthcare-related fields, such as medicine, nursing or sanitary engineering, or equivalent experience in the aforementioned disciplines At least 2-year experience in Drug Development within a pharmaceutical or clinical background At least 2-year experience in system/software project management within a pharmaceutical or clinical background Understanding of the clinical study and drug development process and ICH GCP guidelines in relation to study delivery operational activities Experience in Requirements Gathering preferably within a regulated environment, such as pharmaceutical or clinical area. Experience in Validation/User Acceptance Testing of computerized systems in a regulated environment, preferably the Pharmaceutical industry, including familiarity with documentation such as Validation/Test Plans, Reports, Test scripts (including test scripts execution), Functional Risk Assessment etc. Knowledge of regulatory (GxP, SOX etc.) requirements for computerized systems and infrastructure – understanding of technical documentation Experience working with/on clinical trial software, preferably eCOA system, as end user, tester, project manager, solution designer or other related role. Understanding of Quality Systems and Quality Management, including process definition and improvement, ideally within an Information Systems environment Experience of utilizing standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement Skills and capabilities: Ability to work collaboratively Proven organizational and analytical skills Computer proficiency Strong business communication and presentation skills Knowledge sharing and problem-solving approach Continuous improvement attitude Project and Supplier management skills Date Posted 27-wrz-2023 Closing Date 13-paź-2023 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. AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process. You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.