Real World Evidence Associate

Job title:

Real World Evidence Associate

Company

AstraZeneca

Job description

Introduction to role:Organise cross-functional integrated evidence planning (IEP) activities, aimed to drive medical strategy (i.e., assess evidence needs and gaps, prioritization) in key therapeutic areas (TA). Responsible for the initiation, set-up, conduct and closure of Externally Sponsored Research (ESR) projects. Responsible for fulfilling regulatory and documentation requirements with the conduct of RWE & ESR projects, with a strong focus on GCP & internal SOP compliance, keeping in mind simplification of processes. Support financial milestones tracking activities per project, including PO management & budget oversight.Job Responsibilities:

• Participate in IEP workshops, aimed to include RWE as an integral part of the overall cross-functional evidence generation strategy.
• Join RWE planning within the cross-functional Early Asset Teams (EAT) to identify evidence requirements to feed strategy and to support key-tactics for launch excellence.
• Operational management of RWE projects: study design concept (SDC) & protocol writing, monitor internal & external approvals, coordinate study contracting and submissions, budget & milestones tracking, periodic reports.
• Support, develop & review solid research questions, data dictionaries, statistical analyses plans, shell tables and final reports to create trust in real-world data quality and drive cross-functional implementation.
• Data analyses services and scientific interpretation of RWE outcomes to generate key-strategic insights
• Organization of round-table discussions to accelerate partnerships for RWE generation with internal and external experts.
• Coordination of RWE activities and ensure compliance with relevant legislation, SOPs and GCP, as well as checking compliance with EU/Global GCP lead for primary & secondary data collection for observational studies in Belgium (quality & safety)
• Responsible for ESR coordination and related tasks and act as central point of contact for all study-related items, in close collaboration with the legal sponsor. Activities include, but are not limited to, contract coordination, internal and external communication, coordination of CRO activities, management of investigational medicine products, sponsor oversight plan, internal study documentation and essential document filing (VCV), tracking of study milestones, financial tracking & coordination of potential issues that might bring the continuation of the study at risk.
• Keep data catalogue for ongoing RWE studies in Belux up to date.
• External Service Providers (ESP): ensure that ESP comply with AZ SOPs

Job Requirements:

• University degree in life scientific, engineering or epidemiology field, preferably PhD
• Work experience in (clinical) research, RWD, ore clinical data science
• Ability to understand, initiate, conduct, interpret and communicate data & statistical analyses
• Knowledge of the Belgian clinical trial and health data landscape, ICH-GCP and GDPR

Nice to have:

• (Para) Medical training or pharmaceutical industry experience
• Experience as a project manager
• Experience of diverse range of RWE methodologies, data sources and uses
• Knowledge and experience with relevant AZ therapy areas
• Financial knowledge to set-up and manage study budgets

We offer…When we put unexpected teams in the same room, we fuel bold thinking with the power to encourage life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and ambitious world.Why AstraZeneca?At AstraZeneca, we are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear. We are shaping the future by spotting scientifically-led commercial opportunities and acting now to operationalise and scale them. We are driven by the solutions we bring to the healthcare ecosystem. It powers us to make an impact at every step of the patient journey, improving their experience and outcome. We are constantly thinking big to answer new challenges. We push ourselves to start small and scale fast. The pioneers of digital and innovative solutions that have never been seen before.Ready to make an impact? Apply now and join us on this exciting journey!Date Posted 08-Jan-2025Closing DateAstraZeneca 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.

Expected salary

Location

Ukkel, Brussel

Job date

Fri, 10 Jan 2025 01:32:36 GMT

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