Clinical Trial Manager - FSP

Job summary

Manage clinical trials or programs from initiation through closeout, overseeing vendors, sites, monitoring activities, study documentation, enrollment, and data-related processes. Ensure trials are conducted efficiently and in compliance with GCP, client procedures, FDA and ICH guidelines, while coordinating with cross-functional teams and stakeholders.

Job details

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

What you’ll do

Manage clinical trials or programs from initiation through closeout, overseeing vendors, sites, monitoring activities, study documentation, enrollment, and data-related processes. Ensure trials are conducted efficiently and in compliance with GCP, client procedures, FDA and ICH guidelines, while coordinating with cross-functional teams and stakeholders.

Requirements

Knowledge of GCP and regulatory compliance, along with experience in clinical trial documentation, data management and query resolution, and site management and monitoring procedures. A life sciences degree is preferred.

Listed skills

• Regulatory Compliance · Preferred
• Project management · Preferred
• data management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Clinical Trial Management
• Clinical Trial Oversight
• Vendor Management
• Contract Research Organization Management
• Clinical Trial Documentation
• Protocol Development
• Clinical Site Monitoring
• Good Clinical Practice Compliance
• Regulatory Compliance
• Clinical Research Associate Management
• Patient Enrollment Tracking
• Data Management
• Query Resolution
• Investigator Meeting Coordination
• Trial Master File Maintenance
• Project Management
• Informed Consent
• Monitoring Plan
• Empathy
• Expense Reports
• Research
• Management
• Pre-Clinical Development
• Clinical Monitoring
• Clinical Trials
• Consulting
• DevOps
• Good Clinical Practices (GCP)
• Problem Solving
• Life Sciences
• Operations
• Trial Master File
• Collaboration
• Coordinating
• ICH Guidelines

Job areas

• Healthcare
• Management & Leadership
• Science & Research
• Clinical Trial Manager
• Research and Development Managers
• Clinical Research Coordinators
• Natural Sciences Managers

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