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81839BRJob Posting Title:Senior Manager Clinical Research- Clinical Coordinating CenterDepartment:Pediatrics-Medicine Critical Care AutoReqId:81839BRStatus:Full-TimeStandard Hours per Week:40 Job Posting Category:ResearchJob 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:BostonRegular, Temporary, Per Diem:Regular Remote Eligibility :Part Remote/Hybrid