Operations Specialist, Data Generation, Global Medical Affairs
This is what you will do:
The Specialist provides support for the Data Generation portfolio in Global Medical Affairs. The incumbent will oversee processes, systems and activities related to Data Generation Operations, ensure data is centrally maintained, handled and available to various stakeholders as needed in a timely manner. They will assist with the adoption of innovative approaches to running the portfolio and will collaborate with other business functions within the organization.
You will be responsible for:
- Support day to day Data Generation operations in cooperation with associates across functions, including Legal, Compliance, Finance, Medical and Business Leads.
- Support the Data Generation Operations Lead in the implementation of Global Medical Affairs (GMA) research review processes by facilitating receipt, processing, and cross-functional review of internal and external study submissions.
- Responsible for documentation of review decisions and communication of outcomes to external investigators and internal study owners.
- Responsible for initiating start up activities of Externally Sponsored Research (ESR) studies including development of research agreement, vendor onboarding and purchase order requisition.
- Track the progress of ESR studies ensuring study updates are brought together on an ongoing basis.
- Lead study close out activities for ESRs.
- Organize the bring together, archiving and reporting of all GMA data generation activities.
- Handle all finance related aspects for GMA funded studies – invoicing, accruals, forecasting.
- Identify opportunities for continuous improvement to support audit and inspection readiness.
You will need to have:
- BS degree
- 1-2 years of experience in academic research, pharmaceutical industry, or healthcare
- Experience with enterprise IT systems such as Clinical Trial Management System and study documentation review systems.
- Project management skills including defining project scope, budget, timeline, resource management and use of associated tools.
- Ability to effectively work with Clinical Research Organizations/External Providers/Academic Institutions
- Proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPoint
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
- 2 years+ Experience in Medical Affairs, Clinical Operations or Real-World Evidence Generation
- Experience with external contractor/vendor management.
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.
