Real World Evidence Manager

At AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. Every day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide. Our purpose is results-oriented and so is our approach. Becoming a more agile and creative company means building a dynamic, inspiring culture where we celebrate diverse, bold thinking, are curious, creative, and open to new insights and ways of working. 

Currently we are looking for Real World Evidence Manager, a member of Country Medical Affairs Team responsible for management of scientific evidence & data generation activities across therapeutic areas and along product life cycle. RWE Manager will be responsible for developing and implementing the Country Medical Affairs product-related scientific data generation plan & vision in support of the Country and Regional Medical Affairs and specific therapy area teams

Job Responsibilities

• Mange data gaps identification (gap analysis) and create evidence generation plans in the context of drug development.
• Lead cross-departmental collaboration with the medical department, market access and relevant Bus
• Developing and executing of RWE strategy in collaboration with market access team and medical stakeholders of the relevant BU as well as EUCAN/global in the relevant therapeutic area (close coordination and collaboration with international and headquarters health economics and outcomes research teams, RWE & outcomes research teams)
• Manage generation of real-world data (including, but not limited to):
  • Plan FMV/study budget
  • Identification of RWD sources
  • Contract vendors
  • Identify potential sites
  • Conduct feasibility process (remote or onsite)
  • Compile ethics applications for submission
  • Manage sites contracting
• Oversee study implementation and actively support the analysis and interpretation of real-world data in close collaboration with the external stakeholders involved
  • Identify scientific partners and other relevant stakeholders and build resilient relationships with them
  • Manage health economic analyses (modeling in the area of health economics; cost effectiveness and budget impact analyses)
  • Effectively communicate concepts, project plans, study results and lessons learned with external and internal stakeholders, as well as through scientific publications
  • Create the strategic plan & vision of the LOC Medical Affairs and overall TA Plan to create research and study designs for the generation of scientific evidence along the product lifecycle
  • Ensures processes, strategies, and planning tools related to data generation, as well as the output of statistics and writing
  • Oversees the research, collection and subsequent use of data for clinical, HTA-, regulatory, and additional objectives
  • Works closely with market access, medical, and commercial to align strategies and deliverables
  • Puts in place data management plans, timelines and manages multiple projects through closeout and archiving
  • Designs Case Report Forms, support edit check specifications, support creation of test scripts and tests the related study databases, query processing, and data reporting
  • Leads study start-up activities like training sites, internal users and study project meetings
  • Ensures study data quality by CRF data review, preparation for entry, query processing, discrepancy management, ad hoc reporting, listing generation
  • Creates and maintains all essential scientific data generation & management documentation
• Performs as a point of contact with vendors such as CROs, Database developers, coders, Safety personnel, QA etc.

Typical Accountabilities:

• Develop Evidence Generation process for MC Poland
• Manage end to end preparation, delivery and dissemination of the AZ generated evidence
• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.
• Ensures and monitor compliance by project team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, and (c) immediately addressing and reporting, as appropriate, instances of non-compliance.
• Accountability for GXP areas is expected.

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