[Hiring] Associate Study Administrator, EDC and User Support Level 1 @Premier Research

Role Description

Premier Research is looking for an Associate Study Administrator, EDC and User Support Level 1 to join our Clinical Data Sciences team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. This position provides global EDC User Support to both internal Premier-Research staff and all EDC users, across multiple time zones and countries. Core working hours would be 4 am EST to 12 pm EST. Hours may vary when coverage is needed for team members on leave, which means a second shift might be required a maximum of 20% of the annual working time.

Role Responsibilities

• Responsible for ensuring efficient operation of all aspects including staff availability and ticket resolution.
• 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.
• Focusing on customer support.
• 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.

Accountability

• Ensures timely delivery of a quality technical support service.
• Delivers and maintains user accounts, manages sites within EDC, access to applicable EDC modules.
• Fosters a customer-focused culture.
• Ensures user and site administration start-up 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.

Qualifications

• Undergraduate degree or its international equivalent in science, preferably Computer Science. Demonstrable experience will be considered as a substitute.

Requirements

• Demonstrable experience of implementing process and procedures.
• Demonstrable experience of incident and problem root cause analysis and trend identification.
• Experience in many of the following Software Systems is required:
  • Microsoft Office
  • Adobe Acrobat
  • Internet Explorer
  • Firefox
  • Google Chrome
  • SharePoint
  • Medidata Rave
  • DataLabs
• Familiarity working and supporting a global, distributed, multi-language environment.
• Clinical drug development or other highly regulated industry background preferred.

Expertise

• Microsoft Windows Operating Systems e.g. XP/7/8.1/10.
• Microsoft Office 2003/2010/2013/2016.
• Medidata Rave, DataLabs, or other EDC platforms.

Personal Skills & Behaviours

• Excellent team player; collaborative and effective.
• Ability to multitask and work effectively in a fast-paced environment with changing priorities.
• Strong verbal and written communication skills.
• Excellent organizational and time-management skills, able to prioritize work to meet deadlines.
• Highly motivated with the ability to self-manage assigned or implied tasks.
• Customer service focused in approach to work both internally and externally.
• Maintains a positive, results-oriented approach to the work environment.