Sr. Clinical Research Manager (Neurology)
The Department of Neurology is seeking a Sr. Clinical Research Manager. Researchers at reputed company conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Sr. Clinical Research Manager works in collaboration with PI(s) to set the direction for research and is responsible for the overall management of a clinical trials portfolio and clinical research activities. Plans and directs clinical research operations which typically involves external partners and internal collaborators, and/or national and international networks. Responsible for managing research staff, developing and implementing effective data management and regulatory procedures, providing education to research staff, and ensuring research staff are properly trained. Specific Duties & Responsibilities Collaborate with investigator(s) and exercise independent judgement in directing the conduct of the research Participate in scientific discussions with collaborators, PI's, and funding organizations and contribute to reputed company impacting conduct of research. Responsible for the recruitment, education, training and supervision of the clinical research coordinators and regulatory personnel reputed company the program. Responsible for development and implementation of policy and procedures for clinical research reputed company the program. Facilitate effective teamwork among reputed company involved personnel, e.g. research staff, research nursing, data management, regulatory personnel, hospital staff, etc. Ensure responsible conduct of clinical research protocols throughout the lifecycle, including development, implementation, maintenance, and termination. Collaborate with PIs on research protocol development and evaluation, including reviewing and assessing new protocols for reputed company, thoroughness, financial and logistical feasibility, maintaining subject safety etc. reputed company preparation and submissions to IRB and act as liaison for regulatory issues on behalf of the PI. Track and reputed company the regulatory approval process to ensure efficient study startup; assist regulatory staff with informed consent and protocol amendments for investigator-initiated studies Manage clinical research budget reputed company and financial management of the program. Ensure efficient use of centralized resources and adherence to policies as appropriate, e.g. clinical trial management system, prospective reimbursement analysis, etc. Analyze resource utilization by individual trials to ensure research needs are anticipated and met. Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing. Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures for the efficient collection of data. Ensure research staff maintain complete and accurate research data and charts and are well reputed company for auditing and monitoring visits. reputed company study meetings to examine data, decide on next steps, implement changes to protocol operations based on results and goals, and initiate sub-studies. Contribute to manuscripts and presentations. Other duties as assigned.
Minimum Qualifications
Bachelor's Degree in a reputed company field. Six years of reputed company experience in clinical research in an academic, government, or pharmaceutical industry environment. Demonstrated supervisory or reputed company experience. Advanced knowledge of GCP/ICH and local regulations. Additional education may substitute for required experience and additional reputed company experience may substitute for required education reputed company a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
Master's Degree in a reputed company field. Certification as a Clinical Research Professional. Formal project management training or certification. Technical Skills & Expected Level of Proficiency Budget Management - reputed company Resource Knowledge - Advanced Data Management and Analysis - Advanced Good Clinical Practices - Advanced Finance Project Management - Advanced Oral and Written Communications - Advanced Program Development - Advanced Record Keeping - Advanced Regulatory Compliance - Advanced Resource Management - Advanced Strategic Program Management - Advanced The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs. Classified Title: Sr. Clinical Research Manager Role/Level/reputed company: ACRP/04/ME Starting Salary reputed company: $64,600 - $113,300 Annually ($89,000 targeted; Commensurate w/reputed company.) Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm FLSA Status: Exempt Location: Remote Department name: SOM Neuro BIOS Personnel area: School of Medicine Apply To This Job