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alexion

Clinical Site Solutions Manager

Location: Boston, United States Job reference: R-199912 Date posted: 05/16/2024

This is what you will do:

Clinical Site Solutions Manager (CSSM) within the Clinical Operation Management team, drives delivery of services and technology to Alexion clinical sites locally. The CSSM plays a pivotal role in leading the implementation of non/digital solutions and services for Rare diseases, at the site level. Additionally, you will be responsible for collaborating with internal teams to understand site challenges, identify and implement fit for purpose solutions to support site performance.  

The CSSM will partner with cross-functional teams to ensure successful integration and utilization of site solutions, ultimately contributing to the improvement of site efficiency, and to position Alexion as the Sponsor of Choice for clinical sites. 

You will be responsible to:

  • Lead the planning, coordination, and execution for implementation of site digital solutions including the Direct-to-Patient platform at country and site level for Rare disease portfolio
  • Collaborate with internal stakeholders, including Clinical Operations, Clinical Development, Medical Advisor Pipeline, Digital Health to understand the global and local requirements and ensure alignment with digital  implementation strategies
  • Provide expertise and input to internal Global stakeholders, in the development of digital solutions to meet country and Rare disease requirements
  • Conduct user training sessions and create educational materials to support adoption and effective use of digital solutions as part of broader Digital Health initiatives
  • Collaborate with local study teams to actively support resolution of site and institutional level challenges impacting delivery by identifying and implementing institution fit for purpose resolutions
  • Identify, evaluate, and maintain vendor assessments database for site services and solutions to address site gaps
  • Support vendor contracting, and contract maintenance, working in collaboration with Clinical Operations and Global Strategic Sourcing group
  • Monitor and evaluate the performance of solutions and services, identifying areas of improvement, driving enhancements, and scouting new local vendors for future partnership
  • Routinely review and discuss with local study team site performance metrics for activation and recruitment to identify trends and opportunities for improvement
  • Utilize these insights to explore, develop and implement strategies and innovative solutions to improve institution performance, and drive efficiency at the institutional level
  • Demonstrate comprehensive understanding of external landscape, trends and innovations, acting as SME in site solutions to advise the clinical teams on teams on potential strategies.
  • Collaborate with PMCO, CRA, Site Alliance Lead, MAP, and/or MSL team to create a “One Alexion” mentality

You will need to have:

  • Bachelor degree in related discipline, preferably in computer science, life science, or equivalent combination of education, training and experience
  • Minimum 3 years experience in Clinical Operations within pharmaceutical or clinical background
  • Experience in system/software project management within pharmaceutical or clinical background
  • Solid  knowledge of international guidelines ICH-GCP as well as applicable  regulations and Clinical Trials Process
  • Excellent project management skills with the ability to manage multiple initiatives simultaneously
  • Strong interpersonal, and exceptional organizational skills
  • Proven experience and effective communication skills (written, verbal, and presentation) and demonstrated networking and relationship building skills with internal and external stakeholders
  • Ability to collaborate across diverse functional areas
  • Experience of utilizing standard process improvement methodologies to identify root causes of process issues and identify areas of process improvement.

We would prefer for you to have:

  • Experience in Rare Disease clinical development.
  • Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.
  • Good knowledge of the Drug Development Process.
  • Good understanding of the Clinical Study Process including monitoring, project management, Study Drug Handling Process and the Data Management Process.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. 

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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