Medical IT Specialist

Set-up and support activities associated with the Parexel Safety database including but not limited to:

· New study set-up

· Periodic report configuration and generation

· Ad-hoc report configuration and generation

· Expedited report rule configuration

· End-user support

Set-up and support activities associated with the Safety

Information System (S IS) including but not limited to:

· New study, site, and user set-up

· Report distribution rule configuration

· End-user support

Work closely with Parexel IT, vendor, and/or Parexel Safety Services staff proper analysis, resolution and closure of issues for supported systems

Interface with other Parexel groups (such as TQM, IT) to ensure that database, hardware, network, security, quality, integration, support and project services associated with maintained systems are

adequate and sufficiently managed

Support the handover of the safety database from client to Parexel where contracted to take over the pharmacovigilance tasks for client projects.

Support the handover of safety data from Parexel to client at the end of study/project as contracted

Act as a point of contact both internally and with external clients to develop programs and processes to meet requirements of both clients and regulatory agencies

Provide technology support to Safety Services for the purposes of business process optimization and improvement

Support software updates, change requests and application support for the supported applications

Ensure adherence to regulations concerning computer system validation, 21 CFR Part 11 compliance, procedures, and quality standardsQualificationsSkills:

· Excellent interpersonal, verbal and written communication skills

· Client focused approach to work

· A flexible attitude with respect to work assignments and new learning

· Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail

· Willingness to work in a matrix environment and to value the importance of teamwork

· Excellent problem-solving skills.

· Strong understanding of E2B and Regulatory processes

Knowledge and Experience:

· Experience in the maintenance and support of databases that support a worldwide distributed user base within a regulated industry environment

· Specific experience in one or more of the following areas: ARGUS Safety, ArisG, ORACLE SQL or PL/SQL, VB and any other I.T. discipline that would be of value for safety databases

· Understanding of the Clinical Research and development process including post-marketing approval, in particular with respect to patient safety and regulatory reporting requirements.

· University/College degree with strong technology background.