Associate Director, Site Engagement (Midwest)

AstraZeneca - Wilmington, DE

Full-time

Wilmington, DE

Chemical Manufacturing

About the position

This role is responsible for implementing the operational site relationship management strategy for US SMM at AstraZeneca. The individual will work collaboratively with business stakeholders to position AstraZeneca as the Sponsor of Choice for clinical sites, requiring influential leadership skills and effective collaboration with various functions within the company.

Responsibilities

• Establish strategic partnership models and framework to be deployed across key clinical sites.
• Strengthen relationship between sites and AZ clinical teams to enhance performance and overcome roadblocks in site feasibility, site start-up and execution.
• Support operational feasibility by leveraging AstraZeneca performance data to build realistic, sustainable US recruitment targets and strategies.
• Implement and maintain site partnerships and activities with selected sites.
• Collaborate with local teams 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.
• 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.
• Review site performance to identify trends and opportunities using available data sources.
• Monitor delivery on site partnership agreements and identify challenge areas.
• 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.
• Demonstrate comprehensive understanding of site networks and business practices 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.
• Maintain awareness of marketplace activities, policies, trends, technology, and information affecting the business.
• Collaborate with MSLs and other key clinical and medical colleagues to support site relationships and identify new clinical sites.
• Champion recruitment and retention practices, process improvement within Clinical Operations, and collaborate with internal stakeholders.
• Participate in training and mentoring of new members of the local study teams.

Requirements

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields.
• 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.
• Good analytical skills.
• Good decision making skills.