Iterative Health is seeking a Manager, Clinical Regulatory to join our team. This player/coach will work under the direction of the Director of Clinical Regulatory Affairs with the primary responsibility of assisting with the conduct and compliance of Phase 2-4 pharma sponsored research studies. This position will be a collaborative manager/individual contributor, working with internal stakeholders, clinical sites, and study sponsors–requiring Administrative and Regulatory work. This is an exciting time in the Clinical Research industry! Our team is driving the advancement of research by implementing streamlined processes, with a mission of getting treatment options to patients in a faster, more efficient way.

What you’ll be doing:

• Managing the clinical regulatory team
• Working with clinical site staff on essential document preparation, organization, data entry and Regulatory compliance maintenance
• Facilitating successful study start-up, including clinical site and sponsor communication and status reporting
• IRB submissions on behalf of sites
• Participating in internal and external audits

What we’re looking for:

• Experience managing, developing and growing teams
• Expertise in clinical research, regulatory & compliance and Phase 2-4 sponsored clinical research, with a deep understanding of the site Study Coordinator role
• Previous experience as a clinical research coordinator is valuable
• Skilled at adhering to Good Clinical Practices (GCP), FDA essential documents guidelines, and Standard Operating Procedures (SOPs)
• Experience with project management and/or functional team leadership, with strong organizational, decision-making, time management, multi-tasking and prioritization skills
• Expertise in Adobe, Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams), and clinical trial management system (CTMS)
• Confidence and experience presenting to various internal and external stakeholders