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Associate Clinical Trial Manager - FSP

Parexel International Corporation

Southeast, Remote, United States of America

Job Summary:

This Associate Clinical Trial Manager is the Regional Clinical Trial Operations (RCTO) individual responsible for the coordination of clinical operations required to initiate, execute and complete clinical trials to drive on-time delivery of clinical trial milestones. May act in support or lead role.

Key Accountabilities:

Oversight & Support of Project Cycle:

• Creates and maintains clinical trial documents• Participates in the identification, evaluation, and selection of clinical trial sites• Conducts data review• Responsible for tracking of ancillary and investigational supplies, specimens and/or imaging• Supports Clinical Trial Master System (CTMS) and Trial Master File (TMF) completeness• Supports audit and/or inspection activities• May manage Contract Research Organization (CRO) activities• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors• May contribute to process improvement initiatives and departmental projects

Collaborative Relationships:

• Reports to Parexel (PXL) assigned Line Manager with day-to-day direction from the Client• May act as study lead and participate on the cross-functional study team• May act as mentor for less senior RCTO staff on the study• Supports Clinical Trial Manager(s). Collaborates with internal team members, CROs, vendors and sites

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 complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:• Excellent leadership, communication, and organizational skills• Able to multi-task under limited direction and on own initiative• Ability to proactively handle multiple tasks, manage a diverse range of functional activities andsolve problems simultaneously• Strong communication and inter-personal skills• Highly responsive and proactive• A team player• Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) andother clinical trial systems (e.g., CTMS, electronic data capture and eTMF)• Proficiency in written and spoken English required• Proficiency in local language as applicable• Ability and willingness to travel

Knowledge and Experience:• Minimum of 5 years of relevant clinical trial management experience• Oncology clinical research experience is preferred• Global Clinical Trial Management experience is preferred

Education:• Bachelor of Arts/Bachelor of Sciences or equivalent is preferred or equivalent or any relevant andqualifying training

Job posted: 2023-05-27

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