This role is responsible for ensuring implementation of 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. This role will require influential leadership skills and effective collaboration and partnership with sites, clinical, legal, contracts, global feasibility, CRO partners and other functions within AstraZeneca to develop and manage a best-in-class site relationship model. This role will also support site feasibility.
Must live in the Midwest area
Main Duties & 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 and thereby becoming a partner of choice for the sites.
- Support Operational feasibility -leveraging AstraZeneca performance data to build realistic, sustainable US recruitment targets and strategies, provide early transparency on recruitment strategies (ie, utilization of recruitment or site identification vendors, site-specific recruitment tools.)
- 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 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
- 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
- Maintains awareness of marketplace activities, policies, trends, technology and information affecting the business and organization to support continued improvement of clinical recruitment efforts adhering to company policies
- 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 to facilitate knowledge transfer and best practices
- Participate in training and mentoring of new members of the local study teams ensuring compliance with ICH/GCP and AZ Procedural documents.
Education & Experience 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 (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.
- Good analytical skills.
- Good decision making skills.
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what's next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
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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