Clinical Project Specialist

Position Purpose:

Be responsible for providing co-ordination and operational support to clinical project team/country study team, and be responsible for centralizing 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).

Main Accountabilities and Responsibilities:

1. 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 Country Study Manager (CSM) with well arrangement according to index. Provide support to CSM on study level TMF quality review periodically.

2. Be responsible for clinical trial supplies management including order, tracking, shipment,

retrieval and destruction. Coordinate Country Study Manager (CSM) to order the clinical trial

related supplies within required timeline to ensure study smoothly conducting. If needed, the

procurement team support is required. Track and manage the clinical trial related supplies in a timely manner. Establish and maintain vendor information in internal systems if applicable.

3. Be responsible for study finance management. Support CSM to develop the study specific budget. Conduct study payment application process according to CSM request and track the

study payment and update the payment status in a timely manner; conduct accrual according to

study process provided by CSM. Work as coordinator between CCO and financial department regarding study expense issues, support CSM to identify monthly study expense difference within control report; provide information to local study team if necessary.

4. Be responsible for clinical trial related administrative work. Work with 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 line manager. If needed, on behalf of CSM, upload contracts into internal system to seek approval accordingly.

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

6. Be responsible for clinical research process and trial related system management. Drive the

design /smooth implementation of process related to clinical research. Facilitate implementation of the process, track the process quality in all lines, and generate regular report out for senior manager review. Liaison with CPTS team to ensure standard process related to clinical trial in compliance with ICH-GCP and SOP. Centrally monitoring the effectiveness of clinical trial related system, including Plan Source, CTMS Finance, CTSP, etc. and offer the timely training to provide trainings to team members according to business needs.

7. Be responsible for resource allocation and clinical trial related initiatives. Drive clinical trial

related initiatives to make daily work more agile and periodically collect feedback on the initiatives to improve the effectiveness and productivity.

8. Perform other tasks, as assigned or requested by line manager.QualificationsQualifications:

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.

Influencing-uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.

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.

Other: Availability to travel domestically and internationally, if required.