Process Improvement Manager, Clinical Research Operations

Reporting to the Director of Process Improvement, the Process Improvement Manager supports the design, development, and execution of strategic and tactical process improvement initiatives for Clinical Research Operations across the hospital. The Manager will present potential solutions and provide guidance on improving workflows and procedures for clinical trials. Working closely with the Director, the Manager will assess the sustainability of central services at BCH, including satellites and community partners, ensuring workflows are documented. The Manager will also act as a liaison when necessary. With a focus on enhancing device trials and investigator-initiated trials, the Manager will develop workflows and tracking for non-significant risk devices, serving as the in-house subject matter expert for the BCH Clinical Research Operations team.

The Process Improvement Manager will be responsible for:

• Collaborates with stakeholders across the enterprise to conduct detailed analyses of current workflows for device trials, investigator-initiated trials, and other clinical research processes.
• Aligns processes across departments, proposing improvements to enhance standardization and transparency.
• Provides feedback from the study team's perspective on operationalizing process modifications.
• Works closely with regulatory experts and colleagues to ensure study best practices are aligned with regulatory requirements across all domains.
• Collaborates with the Senior Director of Clinical Research Finance to implement the Clinical Research Finance roadmap, driving enhancements and efficiencies within study teams.
• Partners with Research Administration to vet clinical research cores, particularly fee structures, ensuring compliance with federal guidelines and conducting annual fee reviews.
• Develops and prepares reports and analyses for senior management as requested or deemed necessary.
• Maintains collaborative relationships with peers and colleagues to contribute effectively to the working group's goals and foster a positive work environment.
• May mentor Clinical Research Managers as needed.

In order to qualify, you must have:

• Bachelor's degree in the field of Business Administration, Healthcare Administration, Finance and/or Research AND 7 years of experience in Clinical Research OR Master's degree and 5 years of experience. Open to considering candidates at a Specialist level position with a minimum of Bachelor's degree and 3 years of experience.
• Ability to work independently and within project teams, committees, to attain group goals.
• Analytical skills to collect information from diverse sources, apply professional principles in performing various analyses, and summarize the information and data to solve problems or design relatively complex systems and programs that cross department/divisional lines.
• Proficiency with MS Office applications.
• Excellent facilitation, communication, writing, and mentoring skills as well as the ability to prioritize multiple tasks/projects; advanced interpersonal skills to provide effective consultation and collaboration.

Boston Children's Hospital offers competitive compensation and unmatched benefits including flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.