Sr. Clinical Research Manager (Neurology)

The Department of Neurology at Johns Hopkins University is hiring a Sr. Clinical Research Manager to lead a clinical trials portfolio. This role is for someone with at least six years of clinical research experience in an academic, government, or pharmaceutical setting who has supervised or led staff. You will work with principal investigators to set research direction and manage day-to-day operations.

What you will do

• Collaborate with investigators and use independent judgment to direct the conduct of research.
• Participate in scientific discussions with collaborators, PIs, and funding organizations, and contribute to decisions that affect research.
• Recruit, educate, train, and supervise clinical research coordinators and regulatory personnel.
• Develop and implement policies and procedures for clinical research within the program.
• Facilitate teamwork among research staff, research nursing, data management, regulatory personnel, and hospital staff.
• Ensure responsible conduct of clinical research protocols throughout their lifecycle, including development, implementation, maintenance, and termination.
• Work with PIs on protocol development and evaluation, reviewing new protocols for clarity, thoroughness, financial and logistical feasibility, and subject safety.
• Oversee preparation and submissions to the 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, such as the clinical trial management system and prospective reimbursement analysis.
• Analyze resource utilization by individual trials to anticipate and meet research needs.
• Ensure adequate systems for tracking and reporting clinical research milestones for financial invoicing.
• Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures for efficient data collection.
• Ensure research staff maintain complete and accurate data and charts and are prepared for auditing and monitoring visits.
• Lead study meetings to examine data, decide 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.

What they are looking for

• 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.
• Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma or equivalent, to the extent permitted by the JHU equivalency formula.

Preferred qualifications include a master's degree in a related field, certification as a Clinical Research Professional, and formal project management training or certification.

Technical skills

The role requires advanced proficiency in budget management, clinical resource knowledge, data management and analysis, Good Clinical Practices, finance project management, oral and written communications, program development, record keeping, regulatory compliance, resource management, and strategic program management. Additional technical skills may be required based on division or department needs.

Pay, hours, and location

The starting salary range is $64,600 to $113,300 per year, with a target of $89,000, commensurate with experience. This is a full-time, exempt position. The schedule is Monday through Friday, 8:30 am to 5:00 pm. The location is remote. The classified title is Sr. Clinical Research Manager, role/level/range ACRP/04/ME. The department is SOM Neuro BIOS, in the School of Medicine personnel area.