Warsaw, Poland.
Currently we are looking for Real World Evidence Specialist, a member of Country Medical Affairs Team responsible for scientific evidence & data generation plans & activities across therapeutic areas and along product life cycle. RWE Specialist 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
a. Identify data gaps (gap analysis) and create evidence generation plans in the context of drug development
b. Alignmen 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)
c. Identification and coordination of projects/project management for the generation of real-world data (including, but not limited to):
- Plan FMV/study budget
- Contract vendors
- Identify potential sites
- Conduct feasibility process (remote or onsite)
- Compile ethics applications for submission
- Support sites contracting
- Track the progress of a studies including milestones, patient recruitment, trial supplies and trial documentation
- Take operational and administrative responsibility for local studies and ESRs.
- Track and process invoices and authorized payments tselected vendors and investigational sites, accurately and in a timely manner
d. 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
- Support 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
- Translates the strategic plan & vision of the LOC Medical Affairs and overall TA Plan tcreate research and study designs for the generation of scientific evidence along the product lifecycle
- Ensures processes, strategies, and planning tools related tdata generation, as well as the output of statistics and writing
- 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:
- Execute Evidence Generation process for MC Poland
- Execute 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 appropriate tracking of milestones for AZ studies, compliance with reporting requirements and budget spend
- 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.
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.
Join AstraZeneca and help us deliver life-changing medicines. Be among our employees who continue to make us an innovation-driven company that stands firmly among the world’s leaders in biopharmaceuticals. APPLY!
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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