Premier Research

Administration

• Responsible for ensuring efficient operation of all aspects including staff availability ticket resolution but also with regards to the end user and the ability to assist the technical infrastructure
• Acting as escalation point for all requests
• Developing and implementing EDC User Support process and procedure
• Determining root cause of issues and communicating appropriately to internal and external customers
• Reporting to Manager on any issue that could significantly impact the business
• Suggesting potential improvements to the global end user support experience relative to security, business continuity, service delivery, etc.
• Service Desk ticket triage, assessment, escalation, and resolution
• Technology assessment for browser compatibility for the EDC system
• Training material as necessary
• Study start-up activities, as related to EDC systems
• Study close-out activities, as related to EDC systems
• EDC validation activities
• Ensures timely delivery of a quality technical support service
• Delivers and maintains user accounts, manages sites within EDC, access to applicable EDC modules
• Foster a customer focused culture
• Ensure user and site administration startup tasks are completed, including URL configuration, eLearning set-up, and status trackers
• Manages study close-out activities, as related to EDC systems
• Takes the initiative to identify areas of improvement from both a technical and process perspective, act on these and make recommendations

Associate Study Administrator, EDC, User Support Level 1

Support Engineer

• Investigate and resolve production issues of Remarque Systems software products
• Perform root cause analysis for production errors and recommend improvements
• Collaborate with the support team to ensure efficient issue resolution
• Provide clear and effective communication to users and the support team, offering step-by-step guidance and support throughout the resolution process
• Appropriately escalate production issues that cannot be resolved after analysis
• Participate in the escalation process for unresolved issues and ensure timely resolution
• Create and maintain documentation for common issues
• Collaborate with developers, architects, product owners, and other stakeholders to understand the expected product functionality and customer requirements
• Participate in the technical design of new software components
• Participate in peer code reviews

Technical Support Specialist

Compliance

• Develop and execute regulatory program strategies and contingencies for assigned projects
• Lead both US and ex-US regulatory teams on assigned projects
• Develop and implement creative approaches to ensure regulatory success
• Provide efficient and effective regulatory representation with clients as well as across the organization and act as a key player in interactions with the Food and Drug Administration (FDA) and other regulatory agencies
• Serve as the primary point of contact and interface for FDA/EMA/national agencies on assigned projects
• Lead the preparation of submissions, which may include INDs, briefing documents, orphan drug applications, breakthrough designations, and NDAs/BLAs/MAAs and others

Associate Study Administrator, EDC, User Support Level 1

Technical Support Specialist

Director, Regulatory Affairs