What are the responsibilities and job description for the US Site Engagement Lead position at 4314 AstraZeneca Pharmaceuticals LP Company?
Job Title: US Site Management Lead Location: Field Based Summary: This role is responsible for ensuring implementation of the operational site relationship management strategy (incl partner in care) 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, 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. Job Responsibilities: 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 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 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 MSL team to conduct mutual site exchanges to create a “OneAZ” mentality and support site success Meet regularly with sites in coordination with MSL and Global Site Lead Contribute to process improvements, knowledge transfer and best practice sharing. Education / Sills: 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 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, 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 Integrity and high ethical standards Ability to travel nationally as required. Desirable 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 Date Posted 15-May-2023 Closing Date 25-Jun-2023 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 authorisation and employment eligibility verification requirements. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law. AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process. You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.