"Clinical Research Manager II- Asthma Clinical Research Center"

Department Summary

The Clinical Research Manager II provides senior-level operational, regulatory, and personnel leadership for the Asthma Clinical Research Center (ACRC), a high-volume pediatric clinical research program conducting early-phase, multi-center, observational and federally funded clinical trials focused on asthma and allergic diseases.

The CRM II will oversee the full lifecycle of multiple concurrent clinical trials and ensure compliance with institutional and federal regulations, as well as lead a multidisciplinary team of research coordinators and specialists. The CRM II is responsible for training staff, developing best practices for research operations, managing complex regulatory and recruitment activities, and ensuring studies are executed efficiently and ethically.

This position requires a high degree of independence, strong interpersonal and leadership skills, advanced knowledge of clinical research foundations, and the ability to autonomously manage research operations and competing priorities in a fast-paced academic medical center environment.

Key Responsibilities:

• Manage the daily operations of the Asthma Clinical Research Center (ACRC), ensuring compliance of clinical research activities across multiple concurrent studies.
• Oversee a diverse portfolio of observational and early-phase, multi-center, federally funded (NIH) and sponsor-initiated clinical trials, including investigator-initiated studies.
• Provide comprehensive oversight of regulatory, recruitment, and study start-up activities, including IRB submissions, amendments, continuing reviews, and sponsor/NIH communications.
• Lead, supervise, train, and mentor a team of Clinical Research Assistants, Clinical Research Coordinators, and Clinical Research Specialists, fostering professional development and accountability.
• Conduct annual performance reviews, goal setting, and ongoing performance management for ACRC research staff.
• Independently identify and resolve operational, logistical, and regulatory challenges related to complex clinical trials, escalating issues as appropriate and implementing sustainable solutions.
• Develop and maintain data management, tracking, and monitoring tools in compliance with GCP, NIH requirements, and institutional standards.
• Manage research staffing budgets and study-level finances in partnership with Principal Investigators and departmental leadership.
• Oversee operational logistics and infrastructure planning for the ACRC's clinical research space, including the new research center at 2 Brookline Place.
• Serve as a key liaison between study teams, hospital departments, sponsors, NIH partners, and external collaborators, ensuring clear communication and timely execution of deliverables.
• Model and promote the hospital's core values in all interactions with patients, families, and colleagues.
• Strong working knowledge of GCP, federal regulations, IRB requirements, and institutional research policies.

Minimum Qualifications

Education:

• A Bachelor's Degree is required, a Master's Degree is preferred.

Experience:

• 7 years of relevant post-graduate work experience, including a minimum of two years of managerial experience OR Master's Degree and 5 years of relevant post-graduate work experience, including to years of managerial experience.
• Demonstrated experience managing early-phase and/or multi-center clinical trials, preferably federally funded (e.g., NIH).
• Proven ability to manage multiple complex projects and competing deadlines simultaneously
• Experience supervising and developing clinical research staff in an academic or hospital-based research environment.
• Strong working knowledge of GCP, federal regulations, IRB requirements, and institutional research policies.