Key Accountabilities:
- 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
- Ensures trial master file is current and maintained
- 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:
- 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
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