Ref #: 29607

Employment type: Permanent - Full-Time

Location: China-Shanghai

Description

Main Accountabilities and Responsibilities:

1. Be responsible for clinical trial non-drug supplies management including order, tracking, shipment, retrieval and destruction. Coordinate Clinical Project Leader (CPL)/Country Study Manager(CSM) to order the clinical trial non-drug supplies within required timeline to ensure study smoothly conducting. If needed, the procurement team support is required. Track and manage the clinical trial non-drug supplies in a timely manner; establish and maintain vendor information in internal systems if applicable.

2. Be responsible for Trial Master File(TMF) management including binder set up, document archiving, etc. Set up TMF binder once study kick off and maintain the documents provided by CPL with well arrangement according to index. Provide the support to CPL on study level TMF quality review periodically.

3. Be responsible for study finance management. Support CPL to develop the study specific budget. Conduct study payment application process according to CPL request and track the study payment and update the payment status in a timely manner; conduct accrual according to study process provided by CPL. Work as coordinator between
CMA and financial department regarding study expense issues; support CPL to identify monthly study expense difference within control report; provide information to local study team if necessary.

4. Support CPL on clinical trial related administrative works assigned by line manager. On behalf of CPL, upload contracts into internal system to seek approval accordingly. Work with CPL to support the day-to-day activity of the study, including study progress tracking, document/system data update, problem solving, investigator meeting organization and other activities assigned by line manager.

5. Be responsible for study file archiving (CCO Only). As an expert, be the responsible person to support CSMs to archive the study related records, maintain, retrieve and destruct the records according to CSM request and in compliance with related SOP.

Qualifications:

• College degree or equivalent or above, major in medicine/pharmacy/science related is preferred.
• Experience in Clinical Research/Development or related industry (appreciated).
• GCP/GMP knowledge on clinical supply management.


Skills, Experience and Competencies:

• Managing Work-effectively Managing one's time and resources to ensure that work is completely efficiently.
• Communication-conveys information and ideas clearly and concisely to individuals or
groups in an engaging manner that helps them understand and retain the message;
listens actively to others.
• Work Standards- sets high standards of performance for self and others; assumes accountability for successfully completing assignments; self-imposes standards of excellence rather than having standards imposed.
• Initiating Action-takes prompt action to accomplish work goals; takes action to achieve
results beyond what is required; is proactive.
• Earning Trust- gains others' confidence by acting with integrity and following through on commitments while disclosing own positions; tracts others and their ideas with respect and supports them in the face of challenges.
• Technical/Professional Knowledge and Skills- has achieved a satisfactory level of
technical, functional, and/or professional skill or knowledge in position-related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results.

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