Sr. Clinical Research Manager (Neurology)

About the role

The Department of Neurology at Johns Hopkins University is seeking a Senior Clinical Research Manager to join their team. This position works closely with Principal Investigators (PIs) to direct clinical research operations, manage research staff, and ensure compliance with Good Clinical Practices (GCP) and regulatory requirements.

Responsibilities

• Collaborate with investigators and exercise independent judgement in directing the conduct of research
• Participate in scientific discussions with collaborators, PIs, and funding organizations and contribute to decisions impacting the conduct of research
• Responsible for the recruitment, education, training, and supervision of clinical research coordinators and regulatory personnel within the program
• Develop and implement effective data management and regulatory procedures
• Facilitate effective teamwork among all involved personnel, including 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 clarity, thoroughness, financial and logistical feasibility, maintaining subject safety, etc.
• Oversee preparation and submissions to Institutional Review Board (IRB) and act as liaison for regulatory issues on behalf of the PI
• Track and oversee 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 generation 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 prepared for auditing and monitoring visits
• Lead 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

Requirements

• Bachelor's Degree in a related field
• Six years of related experience in clinical research in an academic, government, or pharmaceutical industry environment
• Demonstrated supervisory or lead experience
• Advanced knowledge of GCP/ICH and local regulations

Qualifications

• Master's Degree in a related field preferred
• Certification as a Clinical Research Professional preferred
• Formal project management training or certification preferred

Skills

• Budget Management - Advanced
• Clinical 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