US Site Engagement Lead

This field-based role is responsible for ensuring the local implementation of the operational site relationship management strategy (incl partner in care) for SMM Oncology 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.

Typical 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 start-up 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 DSMMor 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 start-up and management activities.
• Collaborate with local medical affairs team (including MSL) to conduct mutual site exchanges to create a “OneAZ” mentality and support site success.
• 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.

Minimum Qualifications:

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• Minimum 3 years of experience in Clinical 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.
• Excellent customer management skills.
• Good understanding and keen interest in digital solution and technology.
• Excellent organisational skills and ability to prioritize and handle multiple tasks.
• Excellent verbal and written communication skills.
• Excellent attention to details.
• Excellent knowledge of spoken and written English.
• Good negotiation skills and influential leadership skills.
• Good ability to learn and to adapt to work with IT systems.
• Excellent problem solving and conflict resolution skills.
• Ability to look for and champion more efficient and effective methods/processes of delivering clinical trials to plan focusing on key performance metrics of speed, quality, an