Sr Director New Development RBU, Enterprises - UPMC
Pittsburgh, PA
About the Job
Purpose:
The Senior Director New Development, RBU (Research Business Unit) at UPMC is responsible for setting and driving the strategic direction of the research administration and clinical research support functions across all UPMC locations. The Senior Director New Development leads efforts to ensure regulatory compliance, support the growth of the clinical trials portfolio, and foster collaboration across research and clinical departments. The role encompasses overseeing research support services, refining operational procedures, and working closely with senior leadership to enhance research capabilities and streamline operations.
Responsibilities:
+ Strategic Leadership:
+ Define the strategic direction and implement initiatives to deliver integrated research support services within UPMC's clinical research portfolios.
+ Establish RBU goals and assess outcomes.
+ Oversee research activities across all UPMC locations to ensure compliance with UPMC policies and external regulatory requirements.
+ Lead business development efforts to ensure sustained growth and financial viability of UPMC's clinical trials portfolio.
+ Operational Oversight:
+ Oversee the RBU operations to deliver high-quality research support services.
+ Refine service offerings, policies, and procedures to promote efficiency, enhance user satisfaction, and improve research effectiveness.
+ Ensure the development and maintenance of policies, standard operating procedures (SOPs), and quality assurance processes, holding teams accountable for adherence to best practices.
+ Team Management:
+ Build and maintain a flexible staffing model to meet the needs of UPMC's growing research portfolio, using data-driven metrics to determine staffing levels.
+ Select, develop, and evaluate personnel to ensure the research administration team operates efficiently and scales as needed.
+ Collaboration and Communication:
+ Partner with UPMC leadership, research departments, principal investigators (PIs), Investigational Drug Services (IDS) and other operational leaders to establish workflows, roles, and responsibilities.
+ Ensure effective integration of study startup, regulatory, budgeting, financial, and clinical operations.
+ Participate in UPMC finance meetings and initiatives to align research operations with overall organizational goals.
+ Clinical Trial Management and Oversight:
+ Oversee the planning, implementation, and maintenance of the OnCore Clinical Trial Management System (CTMS) to streamline clinical research operations.
+ Manage external service providers (e.g., Huron) and ensure their deliverables align with UPMC's research goals and standards.
+ Oversee staff responsible for managing UPMC's clinical trials portfolio, ensuring accuracy, timeliness, and compliance with regulatory standards.
+ Process Improvement and Standardization:
+ Lead cross-departmental forums and workgroups to address gaps, foster collaboration, and drive standardization across the research enterprise.
+ Identify and implement process improvement initiatives to enhance the efficiency and effectiveness of research operations.
+ Bachelor's degree in related health sciences field or RN licensure with ten years of experience in clinical research, or an equivalent combination of education and relevant experience required. Master's degree preferred.
+ Minimum five years of directly related professional experience working with research compliance and/or regulatory policies
+ Association of Clinical Research Professionals certification or equivalent preferred
+ Minimum 5 years of managerial experience
+ Demonstrated leadership and strategic skills
+ Experience with research protocols and regulatory or governing bodies, including HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical practices required
+ Strong organization and management skills including planning, assessment, and conflict resolution Licensure, Certifications, and Clearances:
+ Act 34
UPMC is an Equal Opportunity Employer/Disability/Veteran
The Senior Director New Development, RBU (Research Business Unit) at UPMC is responsible for setting and driving the strategic direction of the research administration and clinical research support functions across all UPMC locations. The Senior Director New Development leads efforts to ensure regulatory compliance, support the growth of the clinical trials portfolio, and foster collaboration across research and clinical departments. The role encompasses overseeing research support services, refining operational procedures, and working closely with senior leadership to enhance research capabilities and streamline operations.
Responsibilities:
+ Strategic Leadership:
+ Define the strategic direction and implement initiatives to deliver integrated research support services within UPMC's clinical research portfolios.
+ Establish RBU goals and assess outcomes.
+ Oversee research activities across all UPMC locations to ensure compliance with UPMC policies and external regulatory requirements.
+ Lead business development efforts to ensure sustained growth and financial viability of UPMC's clinical trials portfolio.
+ Operational Oversight:
+ Oversee the RBU operations to deliver high-quality research support services.
+ Refine service offerings, policies, and procedures to promote efficiency, enhance user satisfaction, and improve research effectiveness.
+ Ensure the development and maintenance of policies, standard operating procedures (SOPs), and quality assurance processes, holding teams accountable for adherence to best practices.
+ Team Management:
+ Build and maintain a flexible staffing model to meet the needs of UPMC's growing research portfolio, using data-driven metrics to determine staffing levels.
+ Select, develop, and evaluate personnel to ensure the research administration team operates efficiently and scales as needed.
+ Collaboration and Communication:
+ Partner with UPMC leadership, research departments, principal investigators (PIs), Investigational Drug Services (IDS) and other operational leaders to establish workflows, roles, and responsibilities.
+ Ensure effective integration of study startup, regulatory, budgeting, financial, and clinical operations.
+ Participate in UPMC finance meetings and initiatives to align research operations with overall organizational goals.
+ Clinical Trial Management and Oversight:
+ Oversee the planning, implementation, and maintenance of the OnCore Clinical Trial Management System (CTMS) to streamline clinical research operations.
+ Manage external service providers (e.g., Huron) and ensure their deliverables align with UPMC's research goals and standards.
+ Oversee staff responsible for managing UPMC's clinical trials portfolio, ensuring accuracy, timeliness, and compliance with regulatory standards.
+ Process Improvement and Standardization:
+ Lead cross-departmental forums and workgroups to address gaps, foster collaboration, and drive standardization across the research enterprise.
+ Identify and implement process improvement initiatives to enhance the efficiency and effectiveness of research operations.
+ Bachelor's degree in related health sciences field or RN licensure with ten years of experience in clinical research, or an equivalent combination of education and relevant experience required. Master's degree preferred.
+ Minimum five years of directly related professional experience working with research compliance and/or regulatory policies
+ Association of Clinical Research Professionals certification or equivalent preferred
+ Minimum 5 years of managerial experience
+ Demonstrated leadership and strategic skills
+ Experience with research protocols and regulatory or governing bodies, including HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical practices required
+ Strong organization and management skills including planning, assessment, and conflict resolution Licensure, Certifications, and Clearances:
+ Act 34
UPMC is an Equal Opportunity Employer/Disability/Veteran
Source : UPMC