Additional Information
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
K ey Accountabilities :
Project Supports and Other tasks
Provides co-ordination and operational support to clinical project team/country study team, including centralized management of clinical trial management system, streamlining standard process and optimizing/monitoring trial budget to ensure assigned country level delivery through all phases of study management (start up, recruitment, conduct, follow up and close-out)
Works with Country Study Manager (CSM) to support the day-to-day activity of the study, including study progress tracking, document/system data update, problem solving, project meeting and investigator meeting organization and other activities assigned by client manager. If needed, on behalf of CSM, uploads contracts into the client system to seek approval accordingly
Supports CSM to archive the study related records; maintenance, retrieval, and destruction of the records per CSM request and in compliance with related SOP
Drives and/or facilitates implementation of process and client systems related to clinical research, tracks the process quality in all lines, and generates regular reports for client review. Liaises with Compliance, Process, Training, and Systems (CPTS) team to ensure standard process related to clinical trial in compliance with ICH-GCP and SOP. Centrally monitors the effectiveness of clinical trial related system(s). Provides timely training to team members according to business needs
Drives clinical trial related initiatives to make daily work more agile and periodically collects feedback on the initiatives to improve effectiveness and productivity
Performs other tasks, as assigned, or requested by client manager
Study Finance Management
Supports CSM to develop the study specific budget. Conducts study payment application process according to CSM request, tracks the study payment, and updates the payment status in a timely manner; conducts accrual according to study process provided by CSM. Works as coordinator between Country Clinical Operation (CCO) and financial department regarding study expense issues, supports CSM to identify monthly study expense difference within control report; provides information to local study team if necessary
Trial Master File Management
Manages Trial Master File (TMF) including binder set up, document archiving, etc. Sets up TMF binder once study kick off and maintains the documents provided by CSM according to index. Provides support to CSM on study level TMF quality review periodically
Clinical Trial non-drug supplies Management
Manages clinical trial supplies including ordering, tracking, shipment, retrieval, and destruction. Coordinates with CSM to order the clinical trial related supplies within required timeline to ensure smooth study conduct. If required, involve procurement team support as needed. Tracks and manages the clinical trial related supplies in a timely manner. Establishes and maintains vendor information in internal systems if applicable
Compliance with Parexel standards
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements
Parexel · China