Real World Evidence Manager

Job Description

Introduction to role:

Lead, organize & manage cross-functional integrated evidence planning (IEP) programs, aimed to drive medical strategy (i.e., assess evidence needs and gaps, prioritization) in key therapeutic areas (TA). Ensure evidence delivery of RWE studies within budget and timelines. Manage RWE activities to increase impact and demonstrate value for the organization, including internal and external valorization of RWE study results. Link strategy and deliverables to (pre-) launch excellence for key launches, starting early in the process in prioritized disease areas. Manage the initiation, set-up, conduct and closure of Externally Sponsored Research (ESR) projects, in collaboration with RWE associate. Keep oversight of administrative tasks with a strong focus on GCP & internal SOP compliance, keeping in mind simplification of processes together with RWE associate. Manage financial milestones per project. Assist in contracting negotiations with external stakeholders and participate in external engagements to preserve our leadership position in the real-world health data ecosystem.

Job Responsibilities:

• Lead and manage IEP workshops, aimed to include RWE as an integral part of the overall cross-functional evidence generation strategy.
• Lead 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.
• Perform evidence needs assessments, evidence gap identification & prioritization and setup of fit-for-purpose evidence generation initiatives that are linked to local strategic needs, as defined in the IEP/EAT.
• RWE project lead: Study Design Concept (SDC) & protocol writing in line with evidence needs, internal & external approvals, identification of intermediary parties (if needed), coordinate study contracting, conduct feasibility analyses, submissions, management of external vendors, budget control, follow up of payment milestones, writing of periodic reports.
• Coordination of RWD quality assurance through the design and set up of solid research questions, data dictionary, statistical analyses plan, shell tables and final reporting to create trust and drive cross-functional implementation.
• Manage data analytics services and scientific interpretation of RWE outcomes to generate key-strategic insights.
• Managing successful & timely delivery of RWE projects, with focus on maximizing impact and value for the organization. Integration of RWE tactics in the medical- and brand action plans.
• Collaborate with Medical Affairs Manager (MAM) to identify data-driven transforming care and practice change opportunities
• RWE dissemination: management of scientific RWE publications (abstracts & manuscripts) that include data-driven messages to support medical strategy and policy asks.
• Organize and lead round-table discussions to accelerate partnerships for RWE generation with internal and external experts.
• Management of ESR projects in collaboration with RWE associate.
• Provide input for financial planning cycles in collaboration with RWE lead.
• Support RWE associate with the coordination of RWE activities to 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)
• Communication of RWE study results at relevant congresses/ publication in relevant journals
• Relationship management: Develop and maintain relationships externally with - among others – Healthcare Databases owners, and internally with - among others- Evidence Network, Medical Affairs, Market Access, and Marketing and Sales departments
• Maintaining data catalogue for ongoing RWE studies in BeLux
• Focus on collaboration with RWE associate & cross-functional teams in a matrix structure.

Job requirements:

• University degree in Biomedical/ Pharmaceutical life sciences or engineering, preferably PhD
• 3-5 years of work experience in (clinical) research, RWD or clinical data science
• Ability to understand, initiate, conduct, interpret and communicate data & statistical analyses
• > 3 years of experience as a project manager
• Knowledge of the Belgian health data ecosystem
• Leadership, collaborative working and personal accountability
• Financial knowledge to setup and manage (inter) national study budgets
• Excellent knowledge of GCP
• Excellent command of the English language as well as one of the national Belgian languages (Dutch and/or French)
• Technical skills: Protocol writing, statistics, data science & analytics

Nice to have:

• (Para) Medical training
• Pharmaceutical/ Biotech industry experience
• Experience of diverse range of RWE methodologies, data sources and uses
• Knowledge and experience with relevant AZ therapy areas

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!

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.