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
* 5+ 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