Medical Evidence Delivery Manager

AstraZeneca

  • Taiwan
  • Permanent
  • Full-time
  • 1 month ago
The medical evidence delivery manager would be the key expert to oversight the whole process of responsible local trials to ensure local evidence generation activities, in alignment with TA medical strategies, been delivered on time with high quality. The role would be lead the whole process and provide project management of Local NIS trials including CRO management and global-country coordination, and act as the local ESR coordinator with country medical teams to facilitate ESRs(IITs) submission, approval, and implementation. The role would provide support and advice on the process of clinical trials and studies as an expert or through the supervision of a local or global team.
  • Acts as a country or regional expert supporting the Medical Affairs function and project teams within area of expertise
  • Defines and delivers ESR/NIS training for junior members of the team
  • Contributes to establishing and implementing policies, procedures and standards for own work and work of others, ensuring compliance with internal and external standards and regulations
  • Works closely with Medical Affairs colleagues to execute the Medical Affairs strategy within area of specialism
  • Ensures own knowledge and knowledge of team members of best practices and new relevant developments is up to date
  • Primary contact between Global review and Evaluation group, Evidence Connect operation leader, local MA colleagues and the sponsor/sponsor-investigator of operational activities throughout the life cycle of the ESR
  • Functions as the LREG meeting initiator and facilitator and records meeting outcomes in ESSROS and attend global review TC with responsible MSL and participate in discussion if needed
  • Provides operational support for TW ESR, ensuring compliance with all applicable company policies and process including the of ESSROS.
  • Facilitates and leads the Research Agreement negotiation and execution. Ensures payments are executed in compliance with the agreement
  • Discussion with MSLs and ensure the study documents are prepared using specified templates and undergo review and approval as specified in SOP
  • Primary contact between the external service provider (CRO), study site and local MA colleague. Oversee and track study status and relevant process for the study outsourced to CRO and ensure study timeline and milestone are met according to plan
  • Responsible for ensuring NIS study data and documentation are well collected and filed
Date Posted 07-Jul-2020

Closing Date

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.

AstraZeneca

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