Clinical Trial Manager - FSP

Job Overview

​​The Clinical Trials Manager (CTM) will be a member of client’s Development Operations team. The Clinical Trials Manager will manage individual clinical trials and/or programs as part of the Clinical Trial Working Group.​​ 

Key Accountabilities :   

Oversight of activities   

Manage external vendors and contract research organizations  

Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual  

Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents  

Assist with protocol development and study report completion  

Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols  

Provide guidance, direction, and management to CRAs  

Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities  

Coordinate study supplies  

Negotiate contracts with vendors of clinical trial services  

Review Informed Consent Forms, CRFs, and study related materials  

Plan and participate in investigator meetings  

Assist and support data query process  

Assure regulatory compliance of investigational sites with client’s SOPs and FDA and ICH guidelines  

Ensures trial master file is current and maintained  

Collaborative relationships   

Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials.  

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:   

Oversee all aspects of clinical trials from initiation to closeout, ensuring timely completion within budget through effective project management.  

Identify and resolve issues that arise in a timely manner during trial execution to minimize delays and maintain study integrity, employing strong problem-solving abilities.  

Effectively manage multiple tasks, deadlines, and priorities in a complex clinical trial environment  

Clearly convey information and expectations to cross-functional teams, investigators, and stakeholders  

Knowledge and Experience :   

Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines)  

Experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans)  

Experience of data management and query resolution in clinical trials  

Overall knowledge of site management and monitoring procedures  

Education:   

Degree in the life sciences field preferred  

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