Site Engagement Lead

AstraZeneca•Wilmington, DE

50d

About The Position

Are you ready to make a significant impact in the world of clinical trials? As a Site Engagement Lead at AstraZeneca, you will be at the forefront of implementing the operational site relationship management strategy for SMM Oncology! Your mission is to position AstraZeneca as the Sponsor of Choice for clinical sites, driving collaboration and partnership with various stakeholders, including clinical teams, legal, contracts, CRO partners, and more. This role demands influential leadership and effective communication to develop a best-in-class site relationship model that accelerates study start-up timelines and enhances site patient delivery. AstraZeneca is where innovation meets dedication. With a bold vision to eliminate cancer as a cause of death, we are committed to pioneering new frontiers in Oncology. Our teams are empowered to lead at every level, making courageous decisions driven by patient outcomes. We fuse cutting-edge science with the latest technology, backed by substantial investment, aiming to deliver breakthroughs that transform medicine. Join us in our mission to improve the lives of millions with cancer. Ready to make a difference? Apply now!

Requirements

Bachelor degree in related discipline, preferably in life science.
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 methods/processes of delivering clinical trials focusing on key performance metrics of speed, quality, cost.
Manages change with a positive approach to the challenges of change for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
Ability to work across various studies and indications, collaborate with multiple LSTs and GSTs as needed.
Integrity and high ethical standards.
Ability to travel nationally as required.

Nice To Haves

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.
Good analytical skills.
Good decision-making skills.
Basic ability in handling crisis situations.
Ability to influence strategically and persuade tactfully while maintaining effective organizational relationships.
Knowledge of the latest technical and regulatory expectations.
Familiarity with the latest research and thinking.
Experience in Oncology area.

Responsibilities

Implement and maintain Partner In Care strategies and activities with selected sites. Attend internal PiCN workgroups and discussion sessions. Coordinate presentations and discussions on AZ study portfolio and site inclusion.
Establish strategic partnership models and frameworks across key clinical sites through fit-for-purpose contracts, agreements, and governance models.
Strengthen relationships between sites and AZ clinical teams to enhance performance and overcome roadblocks in site start-up and execution.
Collaborate with local teams across different TAs to actively pursue resolution to study-level challenges.
Develop and maintain a working knowledge of site processes and institution knowledge to guide study teams and leadership in site inclusion and study management decisions.
Define and monitor site performance using objective measurements. Develop site relationship oversight models and state-of-the-art tools and informatics.
Review site performance using available data sources to identify trends and opportunities. Utilize this information with 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 implement actions 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 them within the Leadership Team or manager.
Lead the establishment and evaluation of site-related business processes, including development of new SOPs & work practices.
Demonstrate comprehensive understanding of site networks, business practices, and the competitive clinical trial landscape.
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 during start-up and management activities.
Collaborate with local medical affairs team (including MSL) to conduct mutual site exchanges to create a “OneAZ” mentality.
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.

Benefits

qualified retirement program [401(k) plan]
paid vacation and holidays
paid leaves
health benefits including medical, prescription drug, dental, and vision coverage

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