Description:
This is what you will do:
The Operations Specialist provides support for the Externally Sponsored Research (ESR) program in Global Medical Affairs. The incumbent will oversee processes, systems and activities related to the ESR Program, ensure data is centrally maintained, managed and available to various stakeholders as needed in a timely manner. They will assist with the adoption of innovative approaches to managing the program and will collaborate with other business functions within the organization.
You will be responsible for:
- Support day to day ESR operations in cooperation with staff across functions, including Legal, Compliance, Finance, Medical and Business Leads.
- Identify opportunities for continuous improvement to support audit and inspection readiness.
- Perform tasks in the enterprise ESR tracking system to ensure workflows are proceeding and information is being maintained.
- Liaise with the Medical team, internal support functions and external vendors to ensure processes are followed.
- Initiate ESR site Third Party Due Diligence (TPDD) onboarding tasks to ensure site is onboarded per policy in a timely manner.
- Maintain the ESR site TPDD onboarding and contract review tracker.
- Lead and track ESR study close out activities per the ESR Standard Operating Procedure (SOP)
- Support and maintain study budgeting, including Purchase Orders, invoicing, and payment tracking
- Ensure budget and spend transparency by updating relevant systems
- Reconcile Contracts, POs, and invoices, and process contract amendments
- Lead and resolve outstanding invoice/PO issues and communicate in a timely manner to the study sponsor.
You will need to have:
- BS degree in a relevant field of study
- 1-2 years of experience in 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