This Site Engagement Lead role is responsible for ensuring implementation of the operational site relationship management strategy (including partner in care) for US SMM at AstraZeneca. The individual will work collaboratively with business stakeholders to position AstraZeneca as the Sponsor of Choice for clinical sites. This role will require influential leadership skills and effective collaboration and partnership with sites, clinical, legal, contracts, CRO partners and other functions within AstraZeneca to develop and manage a best-in-class site relationship model that will allow to shorten study start-up timelines and increase site patient delivery.
- 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 start-up and execution and thereby becoming a partner of choice for the sites.
- Collaborate with local teams 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 site development LT or manager on site performance status
- Escalate study or site issues to site development LT or manager if not resolved within a reasonable timeframe
- 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 start-up and management activities
- Collaborate with MSL team to conduct mutual site exchanges to create a "OneAZ" mentality and support site success
- Meet regularly with sites in coordination with MSL and Global Site Lead
- Contribute to process improvements, knowledge transfer and best practice sharing.
Bachelor degree in related discipline, preferably in life science, or equiva lent qualification. Minimum 3 years of experience in Development Operations
(CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
- Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
- Proven experience in building and developing relationships with key institutions.
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
- Good knowledge of the Drug Development Process.
- Excellent understanding of the Clinical Study Process including monitoring.
- Very good understanding of the Study Drug Handling Process and the Data Management Process.
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.
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