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 DSMM or 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.
Essential Qualification
- University degree in Pharmaceuticals, Biology, Medtech, biotechnologies, etc.
- Ability to travel domestically
- A minimum of 6 years of experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required
- Oncology clinical trial experience is required
- Experience in site engagement or an investigator facing role is preferred
- Fluent in English
Desired skills
- 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, to obtain desired outcomes while maintaining effective, positive, organizational relationships
- Knowledge of the latest technical and regulatory expectations
- Familiarity with the latest research and thinking
- Experience in Oncology area
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.