HR Operations Analyst developing agile business solutions for MMC. Focusing on optimization of HR processes and supporting Workday system enhancements with an emphasis on user experience.
About the role
- Supporting clinical trial operations and documentation activities in a global context with a focus on quality and compliance in the life sciences industry.
Responsibilities
- Support CSC team members and Business Operations Management in the following trial specific activities: Quality Reviews, virtual trial master file uploads, document routing, study close-outs, reconciliation reports, data collection, change management, and various CSC related activities.
- Work in a team environment to select and complete various CSC related tasks from a central ticketing system.
- Perform Quality Reviews for clinical studies.
- Perform document checks and uploads in vTMF (trial master file) systems).
- Assist with study close-outs and study reconciliations.
- Perform various data collections and metrics reporting.
- Assist with change management efforts.
- Perform additional standard-work tasks per CSC work instructions and SOP’s.
- Act as a Change Control owner.
- Act as a Non-Conformance / Quality Incident owner.
Requirements
- A university degree or equivalent work experience is required.
- At least 3 years operational experience in clinical trials with a pharmaceutical company and/or a CRO is preferred.
- Prior experience with Clinical Trial supply management preferred.
- Knowledge in drug development, global clinical operations, and strategic planning is preferred.
- Good understanding of the therapeutic areas
- Strong understanding and experience with information systems (e.g. SAP, Clinical Trial Management Systems, Procurement Systems) and financial and contract management aspects of conducting clinical trials is preferred.
- Experience with Microsoft office packages Word, SharePoint, Outlook and PowerPoint is required.
- Strong understanding and experience with Microsoft Excel is preferred - special emphasis on utilizing Excel spreadsheets to solve business inquiries.
Benefits
- Health insurance
- Professional development
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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