Senior Manager Clinical Research- Clinical Coordinating Center

Status

Full-Time

Standard Hours per Week

40

Job Posting Category

Research

Job Posting Description

Position Summary
The Sr. Clinical Research Manager oversees the Clinical Coordinating Center (CCC) for a pediatric critical care clinical trials network of dozens of hospitals and research sites across the US. This high-visibility position will coordinate both local and national teams engaged in complex, multi-site clinical trials and foster communication and collaboration among stakeholders, including physicians, nurses, research staff, statisticians, and others. This position offers the opportunity to make a significant impact on pediatric critical care and requires an exceptional leader capable of inspiring teams and driving excellence across a complex network of partners.

Key Responsibilities

• Network Leadership and Coordination
  • Lead a dispersed team, promoting collaboration and excellence.
  • Act as liaison between CCC and national partners to align goals.
  • Coordinate activities across trial sites and stakeholders.
  • Implement communication strategies for clear and consistent messaging.
  • Promote sharing of knowledge and best practices.
• Meeting Management and Stakeholder Engagement
  • Plan, organize and facilitate regular network meetings and progress reviews.
  • Coordinate meetings with external stakeholders including frontline clinicians, regulatory bodies, sponsors and data safety monitoring boards.
  • Present to national audiences and facilitate multidisciplinary discussions.
  • Document meetings and follow up on action items.
• Project Design, Implementation, and Tracking
  • Manage pediatric critical care trials from design to completion.
  • Apply advanced project management methodologies to monitor site progress.
  • Execute strategic work plans prioritizing clinical urgency and research importance.
• Protocol Development and Standardization
  • Develop standardized protocols tailored to pediatric critical care.
  • Collaborate with experts to ensure protocol quality.
  • Implement protocol revisions consistently across sites.
• Regulatory Compliance and Quality Assurance
  • Oversee submissions to regulators (e.g., IRBs, FDA) and ensure adherence to all applicable guidelines and safety standards.
  • Align regulatory strategies across sites and jurisdictions.
  • Monitor data quality and implement corrective actions.
• Team Leadership and Development
  • Lead and mentor local and national teams.
  • Promote a collaborative and innovative culture.
  • Train site staff and provide ongoing support.
  • Celebrate achievements and address challenges.
• Strategic Planning and Resource Management
  • Create long-term strategic plans for the network.
  • Manage complex multi-site budgets with varied sources of funding.
  • Optimize resource allocation for trial efficiency.
  • Mitigate risks to trial timelines and quality.
• Data Management and Statistical Coordination
  • Work with data teams to ensure robust data collection and analysis.
  • Coordinate statistical analysis plans across trials and sites.
  • Oversee safety monitoring and reporting.
  • Ensure data integrity across the network.
• Patient Recruitment and Site Support
  • Implement patient recruitment strategies tailored to pediatric critical care and track recruitment metrics.
  • Support and encourage site staff to improve enrollment.
  • Engage with patient advocacy groups as appropriate.
• Additional Responsibilities
  • Represent the network at national conferences
  • Contribute to grant applications and funding proposals for network expansion
  • Collaborate with industry partners and other research networks

Minimum Qualifications
Education: 

• Bachelor's or Master's degree

Experience:

• Bachelor's + 8 years relevant work experience OR Master's + 6 years 
• 3 years of managerial experience
• Proven success leading distributed teams and inspiring high performance.
• Strong planning, organizational and project management skill to manage complex, multi-site projects
• Significant experience in pediatric clinical trials or critical care research and deep understanding of regulations.
• Experience with clinical trial management systems and collaborative technologies

Office/Site Location

Boston

Regular, Temporary, Per Diem

Regular

Remote Eligibility

Part Remote/Hybrid