Summary

The Senior Clinical Research Manager oversees the planning, execution, and management of clinical trials within the Center for Research Advancement (CRA), focusing on Pediatric Neurology, Genetics, and Medical Device studies. This role ensures regulatory compliance, quality, and efficiency while managing study assignments, personnel effort, and financial resources. Key responsibilities include monitoring timelines and KPIs (feasibility, activation, enrollment, safety, compliance), driving strategic coordination, and leading workforce management for Neurology and Genetics teams, 
including development, performance, and recruitment. As a member of the CRA leadership team, this position provides operational and strategic direction to advance research excellence.

Job Duties

• Monitor Study Progress: Track and evaluate the performance of clinical trials, ensuring quality of services, adherence to timelines, and compliance with applicable regulations.
• Project Oversight: Provide effective planning, coordination, and oversight of research projects from initiation through completion.
• Site Coordination: Schedule, coordinate, and participate in internal feasibility meetings, pre-site visits, and site initiation visits.
• Quality Assurance: Design, implement, and oversee clinical research quality assurance and quality control programs.
• Protocol Development: Develop, implement, and monitor research protocols, procedures, and processes to ensure consistency and compliance.
• Regulatory Compliance: Ensure adherence to institutional policies and regulatory standards governing clinical research.
• Investigator Support: Assist investigators and research staff with reporting requirements and site visits.
• Staff Supervision: Lead and mentor clinical research and administrative staff; provide training and guidance on regulations, best practices, and operational excellence.
• Training & Onboarding: Develop and implement training programs for new and existing staff; oversee onboarding processes to ensure team members are equipped with necessary knowledge and skills for success.
• Operational Improvement: Drive continuous improvement initiatives by developing, implementing, and maintaining Standard Operating Procedures (SOPs), workflows, and best practices to enhance efficiency and compliance across research operations.
• Other Duties: Perform additional job-related responsibilities as assigned.

Minimum Qualifications

• Bachelor's degree.
• Five years of relevant experience.

Preferred Qualifications

• Bachelor’s degree in a scientific, healthcare, or public health–related field; advanced degree preferred.
• Five years of clinical trial research experience, including oversight of complex studies.
• Two years of direct management or supervisory experience.
• CCRP or CCRC certification required.
• Strong knowledge of federal, state, and institutional regulations governing clinical research.
• Proven ability to manage multiple studies and projects simultaneously and meet deadlines.
• Experience overseeing all study phases, including feasibility, start-up, enrollment, and close-out, in a fast‑paced environment.
• Excellent organizational, leadership, verbal, written, and interpersonal communication skills.