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Senior Manager, Special Projects, Center for Clinical Research Advancement

Integrated Resources, Inc

Boston, MA

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JOB DETAILS
SKILLS
Analysis Skills, Billing, Budget Management, Career Development, Certified Professional Coder (CPC), Clinical Research, Clinical Support, Clinical Trial, Customer Support/Service, Customer/Client Research, Editing, Employee Orientation, Establish Priorities, Feasibility Analysis, Fee Schedule, Finance, Financial Compliance, Financial Risk, Healthcare, Hospital, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Interpersonal Skills, Leadership, Mentoring, Operations Processes, Operations Research, People Management, Policy Development, Policy Implementation, Process Analysis, Process Improvement, Program Evaluation, Project Development, Regulations, Regulatory Compliance, Research Administration, Risk, Risk Management, Servant leadership, State Laws and Regulations, Statutory Laws, Strategic Planning, System Integration (SI), Systems Analysis, Team Player, Training Program, Training/Teaching, Training/Teaching Curriculum, Training/Teaching Materials
LOCATION
Boston, MA
POSTED
18 days ago
POSITION SUMMARY:
Reporting to the Senior Director, Center for Clinical Research Advancement (CCRA), the Senior Manager, Special Projects, combines generalist and specialist perspectives with dedication to servant-leadership and scientific innovation. Equipped with extensive experience in program and system design and implementation; integration of research compliance requirements into operational workflows; formation and leadership of institutional committees and workplan initiatives; and career and cultural development, the Senior Manager, Special Projects, is adept in shifting priorities as needed, ready to take on a wide variety of institutional interests. The position has two primary responsibilities: 1. collaborates with the CCRA on the development of the CCRA's inclusive science initiatives and operational efficiencies, and 2. supports all Research and Sponsored Programs (RSP) with compliance-assurance processes and implementation practices. The Senior Manager, Special Projects, has extensive experience in research billing and finance and leads discussions to monitor and improve policies, workflows, system implementation, and education for all BClientHS hospitals.


ESSENTIAL RESPONSIBILITIES / DUTIES:
1. Clinical research billing and finance (CRBF) process improvement and compliance assurance for all clinical research
" Continually assess processes and systems for improvement
o Analyze present state aProductst statutory, regulatory, and coverage determinations
o Recommend process and systems enhancement to Clinical Trial Office Director and collaborate with BClientHS research and non-research departments to implement changes within Client and BClientHS wide systems, including but not limited to, Epic enhancements and other affiliated system integrations
o Support design of research billing workflow integration at sister hospitals and clinics
o Develop and support research fee schedule updates
o Oversee implementation of transparent audit trails into existing workflows
o Develop workflows to confirm all sponsor types and forms for PI engagement are integrated into the CRBF workflow that need to be
" Collaborate with Research Compliance to develop a routine research billing audit plan
" Apply advanced expertise in high-risk clinical research billing compliance and related financial risks
o Identify clinical research and finance policy and education needs
o Design, implement, and expand educational offerings toward risk-reduction
o Mentor and guide staff toward independent expertise
" Support Clinical Trial Office Director and research billing specialists to identify new research billing goals and initiatives
o Provide internal training, programming assistance, evaluation
o Meet regularly to review and improve workflow and current research billing compliance concerns
" Design, launch, and present educational programming
o Create and perform education for research community when necessary
o Mentor staff in training materials production, scheduling, and delivery
" Stay abreast of regulatory changes and newly identified challenges
o Share policy and process innovations and supporting compliance assurance measures
o Translate national findings into institutional practices

2. Support the development and implementation of projects prioritized by Research and Sponsored Programs (RSP)
" RSP special projects development
o Support ongoing analysis of clinical research pipeline and develop plan to address portfolio gaps based on BClientHA patient population and market growth areas
o Design outreach and provide ongoing support as the RSP Navigator for the Client research community to direct them to the right resource or team to address operational research questions
o Design a Principal Investigator (PIs) Initiated strategic plan with implementation stages which includes
" Pilot program or select PIs to navigate support services to design and implement PI initiated studies at BClientHS , including but not limited to clinical trials
" Identify available resources, including needed mentoring, partnerships, for example, SRG, scientific writing core, CCRO, biostats core, IRB, budget development]
" Develop path from pilot to full programming
o Oversee PI-Trialist Training Program
" Gather PI-trialist mentors
" Support PI-Trialist training curriculum
" Match mentors and PI-Trialists
" Support post-training follow-up working groups
" Provide on-going program support
o Additional projects identified as priorities by VP/CSO and/or Senior Director, CCRA
o Design and lead implementation of pilot career development programming within the CRCE, with potential extension across RSP
o Mentor staff, providing guidance on professional growth and career progression
o Advise and support growth of inclusive science workforce
o Analyze feasibility of expanding programming across the research community
o Recommend research community-wide career and culture initiatives
" Policy and educational programming
o Collaborate with RSP directors on educational priorities, appointment of subject matter experts/committee members, integration of policy and education programming
o Create, oversee implementation of strategic policy and education plans
" Form, stand up, and advise a an RSP policy committee
" Form, stand up, and chair an RSP education committee
o Advise RSP policy owner/committee chair on policy style, writing, programming; collaboration with subject matter experts; alignment of policy directives, procedural job aids, and committee direction
o Offer new employee training series to orient personnel to Client s history, mission, organization and RSP structures
" Serve as RSP navigator to support research questions and guidance on available resources for research and RSP communities
" Develop back-up coverage to run training as secondary resource
o Collaborate with Clinical Research Resources Office (CRRO) to identify and make recommendations or develop training and educational materials that address all aspects of the clinical research lifecycle
o Work in partnership with The Research Attorney on policy review, and sometimes, policy drafting when necessary
" Support transition of policy finalization to develop educational content with RSP assigned SMEs

EDUCATION:
Master s degree in related field.

CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED:
Relevant certifications welcomed but not necessary and may include CPC- Certified Professional Coder and CHRC- Certified in Healthcare Research Compliance


EXPERIENCE:
Extensive experience in research administration, policy and education development, process improvement, systems design and integration, and professional mentorship

KNOWLEDGE AND SKILLS:
" Evidenced ability to develop and implement strategic plans in complex institutional environments
" Strong expertise in research compliance, particularly clinical research billing and finance
" Exceptional advisory and interpersonal skills, with experience guiding career development
" Commitment to fostering a diverse, inclusive, and supportive academic culture
" Ability to work collaboratively with institutional leadership while maintaining an independent advisory role
" Readiness to shift accountabilities as needed to take on high-priority special projects
" Ability to apply a generalist perspective that enhances specialist contributions
" Excellence in writing and editing

About the Company

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Integrated Resources, Inc