Clinical Trial Manager - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's 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 we're committed to making a difference.

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