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.