Operations Specialist, Data Generation, Global Medical Affairs

at  Alexion PharmaceuticalsInc

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.