Senior Manager, Heor Real World Evidence Excellence - Barcelona, España - AstraZeneca

AstraZeneca

Empresa verificada

Barcelona, España

hace 3 semanas

Publicado por:

Isabel García

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Descripción

Senior Manager HEOR Real World Evidence Excellence Position Summary The HEOR RealWorld Evidence (RWE) Senior Manager is part of the global HEOR team.

He/she will work with the RWE Centre of Excellence team, the International and Japan HEOR team, and the Medical Affairs RWE Champions in countries to support the development of the strategy, planning and execution of RealWorld Evidence (RWE), RealWorld Data (RWD) projects and noninterventional studies (NIS) in countries and across the international region.

The HEOR RWE Excellence Senior Manager will be responsible to provide support to RWE strategy development, planning, implementation and execution of prospective and retrospective RWE studies including study deliverables, milestones, documentation, and communication.

He/She work closely with crossfuntional Medical Affairs team to follow and report Alexionsponsored RWE study approval and progesion regularly.

He/She will also work closely with and manage CROs in the setup, implementation and follow up of the progression of RWE studies, up to completion and deliverables of the report and publications, whenever required.

Principal ResponsibilitiesDeveloment of RWE strategy, tactic & implementation plans of noninterventional studies and other RWD projects run in countries and acrros countries in the region:

Work sidebyside with regions/countries to identify relevant evidence gaps, prioritize RWE needs, develop, and implement innovative solutions to close the gapsSupport the development of RWE strategies in the region across therapeutic areas, in collaboration with internal partnersWork closely with countries to facilitate the development of local RWE strategy, from study ideas to synopisis development in a timely manner, to produce meaningful and robust evidence to support product value demonstration aligned with local and regional needs (patient access, reimbursement, medical education, and patient advocacy).Develop strong internal and external partnerships to promote effective collaborations to generate high quality RWE across multiple countries Lead definition of standards and processes to manage quality, consistency, usability, security, and availability of RWE data.

Defining / monitoring and tracking of RWE Study timelines and budgets with internal / external partners as well as Study Specific KPIs.

Drive strategic planning and facilitate execution and close out of implementation of noninterventional studies (NIS) in close collaboration with the responsible CRO.Management and oversight of CRO to ensure the appropriate scope of work, oversight, and achievement of study milestones within agreed upon timelines and budget.

supporting the operational aspects of the work, such as ongoing study management, communication with CRO/centers including contracting activities to license and onboard database(s).

Coordinate Internal review of RWE Study proposals in alignment with study review committee.

Ensure proper documentation/availability of RWE Study documentation in a Master file on the right ALXN repository either at local or regional or global level, to ensure audit readiness.

EducationAdvanced degree (Master of Science, MD or PhD) or equivalent ideally in health economics, finance/economics, epidemiology, data science, econometrics or mathematics CompetenciesFluent in English (spoken and written) Demonstrated project management experience or PMP certificationAbility to work effectively, independently, and in a matrix team environmentExcellent communication, interpersonal, and organizational skills Should be highly motivated and work well with mínimal supervisionKnowledge and experience about the rules and regulation regarding reporting of NIS and RWE studies in Europe, document maintenance in case of an external audit