Senior Clinical Project Specialist

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.

Key Accountabilities:

Project Supportsand 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 withCountry 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; maintenanceretrievaland destruction of the records per CSM request and in compliance with related SOP

• Drives and/orfacilitatesimplementation 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. Centrallymonitorsthe effectiveness of clinical trial related system(s). Providestimelytraining 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 thestudyspecific budget. Conducts study payment application process according to CSM request tracks the study payment and updates the payment statusin a timely manner; conducts accrual according to study process provided by CSM. Works as coordinator betweenCountry Clinical Operation(CCO)and financial departmentregardingstudy expense issues supports CSM toidentifymonthly study expense difference within control report;providesinformation 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 studykickoff andmaintainsthe documents provided byCSMaccording to 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 withinrequiredtimeline to ensure smooth study conduct. If required involve procurement team support as needed. Tracks and manages the clinical trial related suppliesin a timely manner. Establishes andmaintainsvendor information in internal systems if applicable

Compliance with Parexel standards

• Complies withrequired training curriculum

• Completes timesheets accurately asrequired

• Submits expense reports asrequired

• Updates CV asrequired

• Maintains a working knowledge of andcomply withParexel processes ICH-GCPs and other applicable requirements

Skills:

• Managing Work - effectively manages ones 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 andretainthe 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 whiledisclosingown 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 ifrequired.

• 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 toaccomplishresults.

Education:

• College Degree or equivalent or abovemajorin Medicine/ Pharmacy/ Science related is preferred.