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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