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Local Study Associate Manager

Местоположение Уилмингтон, Делавэр, США Идентификатор вакансии R-085038 Дата публикации 06/23/2020

As a Local Study Associate Manager, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

As a Local Study Associate Manager (LSAM) you will lead and coordinate activities that ensure quality, consistency, and integration of study data and progress operational deliverables to time cost and quality objectives from Study start-up through study close-out activities and Clinical Study Report (CSR). Work with US local study team, with internal and external partners, on local studies across different phases of drug development and different therapy areas.

Major responsibilities

  • Coordinate operational aspects of AZ Sponsored studies from Study start-up through  CSR/Publication.
  • Interface with field monitoring CRAs, Local Study Manager (LSM) and global study team (GST)
  • Ensure the supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers as appropriate
  • Monitor study conduct and progress, proactively identifying and resolving with the LSM issues which may impact the delivery of the study or to the necessary quality, timeline or budget objective
  • Contribute to the development of Operations documents as appropriate as well as any updates/amendments to those documents

Minimum Requirements

  • Bachelor of Science degree in a related discipline, preferably in medical, biological, or health-related sciences, or equivalent work experience in directly related fields
  • Experience working on clinical studies, across different phases of drug development
  • Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to study delivery operational activities

Essential Qualifications:

  • Relevant industry or health care experience
  • Proven organizational and analytical skills
  • Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to study delivery operational activities
  • Computer proficiency
  • Excellent knowledge of spoken and written English
  • Demonstrates ability and willingness to work and lead cross-functionally, e.g. with internal and external partners, on global studies, across different phases of drug development or different therapy areas
  • Good understanding of clinical data flow
  • Excellent verbal and written communication and presentation skills
  • Demonstrates ability to work independently, as well as in a team environment
  • Excellent interpersonal skills and proven ability to facilitate team building and team work
  • Willingness to travel both domestically and internationally
  • Demonstrates sound knowledge of GCP, AZ Procedural documents, as they pertain to Study delivery systems and processes
  • Proactively identifies risks and issues and possible solutions
  • Demonstrates high standards and uses tactful persuasion to obtain desired outcomes while maintaining effective, positive, organizational relationships
  • Develops knowledge of therapy area through experience and review of scientific literature, and demonstrates the ability to learn new therapy areas
  • Demonstrates ability to prepare and deliver study related training materials
  • Ability to work in an environment of remote collaborators

Desired Qualifications:

  • Demonstrated Project Management skills (e.g. leading delivery team)
  • Excellent mentoring skills and ability to develop others
  • Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
  • Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
  • Good analytical and problem-solving skills.
  • Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
  • Familiar with risk-based monitoring approach including remote monitoring.
  • Good cultural awareness.
  • Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
  • Team oriented and flexible; ability to respond quickly to shifting demands and opportunities

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

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 authorisation and employment eligibility verification requirements.

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