Description
Responsibilities:*Manages the operational aspects of clinical trials
*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
*Prepares metrics and updates for management, as assigned
*Proactively identifies potential study issues/risks and recommends/implements solutions
*Participates in and facilitates CRO/vendor selection process for outsourced activities
*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 (GCP) and applicable regulations
*Participates in the development, review and implementation of departmental SOPs and processes
*Recommends and implements innovative process ideas to impact clinical trials management
*Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
*Serves as a liaison and resource for investigational sites
*Reviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
*Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
Requirements:
*A Bachelor degree in a science or health related field required
*6+ years of related clinical trial management experience
*Experience in managing CROS, specialty labs and outside vendors
*Experience with international trials
*Experience with rare disease desired
*Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment
*Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
*Must be willing to travel 20-30% of time
*Ability to deal with time demands, incomplete information or unexpected events
*Ability to provide clinical expertise to a clinical development in a specified product area or project
*Must possess excellent interpersonal skills
*Must have the ability to build and maintain positive relationships with management, peers, and direct reports
*Excellent written and verbal skills required. Must display strong analytical and problem solving skills. Attention to detail required.