Process Specialist

Parexel International Corporation

Shanghai, Shanghai Municipality, China


Patient Data tracking and updates

• Ensure timely tracking of enrolment data

• Ensures to keep the study specific tracking data base up to date with relevant patient information from the clients IVRS and patient discontinuation reports

Client reports

• Supports preparation and sharing of client specific trendline reports with project managers and or client teams

Case Management:

• Ensures that case assignment is performed according to the global guidelines such as SOPs and work instructions and within the defined timelines

• Identifies the cases which need to be assigned for independent central review based on study specific instructions

• Checks the status of these cases and collaborate with process groups to resolve any issues which are blocking the case assignment

• Prepares clean cases for assignment

• Uploads clinical dossiers applicable for assignable case

• Co-ordinates with reviewers (internal and external radiologists or scientific experts) on schedules for performing independent reviews

• Monitors the status of assigned cases and follows up as needed until review completion

• Acts as a point of escalation for reviewers on read related issues

• Sends results to sites as applicable after review completion

• Reports read status to Project Manager and/or Imaging operations Lead them of any issues or expected delays

Data Reconciliation:

• Performs data reconciliation, in collaboration with Project Manager / Imaging Operations Lead and data operations team

• Pulls reports from Tracking, (based on study needs and timelines) and provides the reports to data management teams outside of Imaging

• Receives data reports from external data management vendors or sponsors and forwards those to Imaging data management team for reconciliation

• Checks discrepancies flagged in the data reconciliation report and performs appropriate actions until resolutions

• Collaborates with the process group as needed to get discrepancies resolved (meta data changed or query raised)Qualifications• Previous Team co-ordination experience preferred

• Good knowledge on Clinical Trials preferred

• Minimum 1 year experience as an IRA II or SIRA if applicant is internal candidate and minimum 3 years of work experience in relevant field if external


2021-08-05 00:05:29


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