Site Engagement Lead

1 semana atrás

São Paulo, São Paulo, Brasil AstraZeneca Tempo inteiro
AstraZeneca is one of the most fascinating biopharmaceutical companies in the world.

From researchers to sales people, from lab technicians to the legal department, we all have a mission to turn ideas into science, science into revolutionary medicines that save and extend patients'; lives and benefit society.

Our portfolio is solid and our pipeline is innovative with a focus on biological medicines in the Cardio-Metabolic, Respiratory and Oncology areas.


Main accountabilities:

  • Implement and maintain Partner In Care strategies and activities with selected sites. Attend internal PiCN workgroups and discussion sessions. Work with AZ PiCN to coordinate presentations and discussion on AZ study portfolio and site inclusion;
  • Establish strategic partnership models and framework to be deployed across key clinical sites through fit for purpose contracts, agreements and governance models;
  • Strengthen relationship between sites and AZ clinical teams to enhance performance and overcome roadblocks in site startup and execution and thereby becoming a partner of choice for the sites;
  • Collaborate with local teams across different TAs to actively pursue resolution to study level challenges;
  • Develop and maintain a working knowledge and materials of site processes and institution knowledge to guide study teams and leadership to positive decisions related to site inclusion and study management;
  • Define and monitor site performance using objective measurements. Develop site relationship oversight model and state of the art tools and informatics. Manage site interactions effectively to ensure alignment of site and business expectations;
  • Using available data sources, review site performance to identify trends and opportunities. Utilize this information with both local and external stakeholders to drive performance;
  • Actively monitor and report study level metrics for activation and recruitment;
  • Monitor delivery on site partnership agreements, identify challenge areas and implementation action to drive success;
  • Routinely update TA DSMM or manager on site performance status
  • Escalate study or site issues to TA DSMM or manager if not resolved within a reasonable timeframe;
  • Gain a clear understanding of the site team needs and communicate that within Leadership Team or manager;
  • Lead the establishment and evaluation of site related business processes including development of new SOPs & work practices, ensuring consistency in site management policies and procedures;
  • Demonstrate comprehensive understanding of site networks and business practices and the competitive clinical trial landscape in order to advise clinical teams on study specific site selection or site management strategies. Support local feasibility lead and LSAD in site identification and selection. Provide cross study knowledge sharing with applicable internal teams when appropriate;
  • Propose and drive efficiency opportunities at the site level and within the SMM team interactions with the site during startup and management activities;
  • Meet regularly with sites in coordination with local medical affairs (including MSL) and Global Site Lead;
  • Contribute to process improvements, knowledge transfer and best practice sharing.

Requirements:

  • Bachelor's degree in health area;
  • Oncology knowledge;
  • Fluent in English;
  • Experience in Clinical Operations (CRA, Sr CRA) or other related fields (Medical Affairsled or Academicled studies);
  • Good knowledge of international guidelines ICH-GCP as well as relevant local regulations;
  • Availability for national trips (30% time).

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