Description
Manages the study project plan, including timeline, budget, and resources
Participates in study strategy development, protocol, CRF development, Clinical Study Report preparation, NDA submission, as appropriate
Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
Manages clinical monitoring activities ensuring compliance with Good Clinical Practices and applicable regulations
Participates in the development, review and implementation of departmental SOPs and processes
Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
Serves as a liaison and resource for investigational sites
Requirements: A Bachelor degree in a science or health related field with over 5 years experience in clinical trial management; Experience managing CROs and other outside vendors; International Study Management; Infectious Disease experience preferred; Must be willing to travel up to 30%; Knowledgeable of clinical research operations including ICH guidelines
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