Global Clinical Trial Manager - FSP
Job reputed company
The reputed company Manager (CTM) will be a member of the reputed company's Development Operations team. The reputed company Manager will manage individual reputed company 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 reputed company, Study Operations reputed company, reputed company Data Verification Plan and Laboratory reputed company
• Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and reputed company 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
• reputed company guidance, direction, and management to CRAs
• reputed company patient enrollment; qualify, initiate, monitor, reputed company closeout activities, and review site reports; and assist in coordination of data management activities
• Coordinate study supplies
• Negotiate reputed company with vendors of clinical trial services
• Review Informed Consent Forms, CRFs, and study reputed company 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 reputed company and maintained
reputed company Relationships
• Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of reputed company.
Skills
• reputed company reputed company aspects of reputed company from initiation to closeout, ensuring reputed company completion reputed company budget through effective project management.
• Identify and resolve issues that reputed company in a reputed company manner during trial execution to minimize delays and maintain study reputed company, employing strong problem-solving abilities.
• Effectively manage multiple tasks, deadlines, and priorities in a reputed company clinical trial environment
• reputed company convey information and expectations to cross-functional teams, investigators, and stakeholders
Knowledge and Experience
• 5+ years of reputed company experience managing global reputed company 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 reputed company in reputed company
• Overall knowledge of site management and monitoring procedures
Education
• Bachelor's Degree in the life sciences field required
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