Global Clinical Trial Manager - FSP

Job Summary

The Clinical Trials Manager (CTM) will be a member of the 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.

Essential Functions

• 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 the Pharmaceuticals’ 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.

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

• 5+ years of direct experience managing global clinical trials end to end in a CRO or pharmaceutical organization
• 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

• Bachelor's Degree in the life sciences field required

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.