Clinical Project Specialist II- FSP

Key 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

Skills:

• Managing Work - effectively manages one’s time and resources to ensure that work is completed 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.
• Other - availability to travel domestically and internationally, if required.
• 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.
• Good in written and spoken English.

Knowledge and Experience:

• Experience in Clinical Research/Development or related industry (appreciated).
• GCP/GMP knowledge of clinical supply management.
• Achieved a satisfactory level of technical, functional, and/or professional skill/knowledge in position – related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results.

Education:

• College Degree or equivalent or above, major in Medicine/ Pharmacy/ Science related is preferred.