Senior Clinical Project Manager
- Develop and(or) manage contracts, budgets, schedules, and performance requirements.
- Manage and(or) coordinate the activities of projects with responsibility for results in terms of costs, tasks, methods, resources, timelines and study completion.
- Function as the main point of contact for sponsors with the FCS project team
- Maintain efficient communications among sponsor, clinical sites, and FCS internal functional team members.
- Regularly communicate and report with senior management on matters concerning resource allocation, project milestones, regulatory issues, project financial performance, and other relevant issues.
- Direct the setup and maintenance of a Trial Master File at FCS as a repository for study documents.
- Write and/or review clinical study-related documents including protocol, Informed Consent Form (ICF), and Clinical Study Report (CSR).
- Assign and coordinate Clinical Research Associate (CRA) study site monitoring activities.
- Monitor progress in evaluating, initiating, monitoring, and closing out study sites.
- Monitor weekly patient enrollment.
- Monitor overall progress in retrieving/completing case report forms (CRF/eCRF) and data query resolution.
- Review project correspondence among sponsor, FCS project personnel, and study site personnel.
- Review monitoring visit reports, and assist in problem solving study site-related issues.
- Selectively co-monitor at study sites and conduct in-house and on-site training of CRAs for pre-study site evaluations, study initiation visits, study monitoring visits, study close-out visits, and related activities.
- Coordinate problem solving of diverse scope where analysis of data requires evaluation of identifiable factors.
- Exercise judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Act as advisor to subordinate(s) and/or mentees to meet schedules, and/or resolve technical problems.
- Good communication skills with the ability to interface at all levels of management.
- Manage and foster positive and productive relationship with all project team members and customers of FCS.