Senior Director Chief Clinical Research Officer

J  o  b    D  e  s  c  r  i  p  t  i  o  n

JOB INFORMATION

Effective Date:

2/24/2025

Entity:

Wisconsin

Job Code:

103021

Job Title:

Senior Director Chief Clinical Research Officer

FLSA Exemption Status:

Exempt

Management Level:

Director/Senior Director

JOB SUMMARY

The Senior Director, Chief Clinical Research Officer (CCRO) is responsible for developing and providing an efficient and compliant environment to conduct clinical trials for the academic health system (AHS). The CCRO leads strategic planning, goal setting, and implementation of the infrastructure, processes and systems to support efficient and high-quality clinical trials at The UW School of Medicine and Public Health (SMPH) and UW Health. The CCRO is responsible for:

• Working collaboratively with the SMPH Office of Biohealth Industry Partnerships to engage current and new sponsors, as well as maintaining sponsor relationships to establish UW as a premier clinical trials organization and UW Health as a premier clinical trials site.

• Leading strategic planning exercises to identify areas for growth in clinical trials that complements UW Health priorities and where SMPH are thought leaders.

• Establishing a user-friendly single point of entry for clinical trial sponsors.

• Working with others throughout the University (e.g., Office of Vice Chancelor for Research (OVCR), Institute Review Board (IRB) leadership, SMPH Dean's office) to identify and implement improvements in contract, regulatory, and scientific review processes and protocol submissions to oversight committees.

• Developing a nimble strategy for study support and the tracking of key metrics and using these for continuous improvement. In addition, policies that promote acculturation of clinical trials in the health system and systematize recruitment strategies, such as opt-in/ opt-out programs will also be under the CCRO's purview.

• Striving for implementation of a quality system that meets global quality standards by conducting an environmental assessment and identifying areas for process improvement to establish the AHS's quality system.

The CCRO is responsible to the Chief Clinical Officer and the SMPH Senior Associate Dean for Basic Research, Biotechnology and Graduate Studies.

ESSENTIAL DUTIES

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Provides an experience and environment of patient- and family-centered care.

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Interprets impact of broad scope organizational change for staff and develops change strategies for successful implementation.

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Incorporates UW Health’s vision, missions and values in goals and programs within the department.

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Develops and manages operational initiatives with measurable outcomes.

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Formulates objectives, goals and strategies collaboratively with other stakeholders.

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Prepares and delivers reports to operational leadership outlining progress toward meeting annual goals and objectives, to include performance related to finance, clinical activity, quality, safety, marketing, and human resources.

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Actively seeks opportunities to improve financial outcomes, engaging staff in the process.

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Establishes annual financial goals and actively uses benchmarking to high performing systems in similar area of expertise to set annual targets.

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Monitors and analyzes financial data and utilizes for decisions regarding FTE’s, staffing and operational budget. 

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Establishes an annual operating and capital budget, demonstrating fiscal responsibility through meeting budget targets.

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Creates business plan(s), justifying variances and analyzing cost benefit of programs.

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Directs and provides guidance to managers to effectively allocate resources based on patient volume, space availability, budget constraints, and program priorities, goals and objectives.

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Articulates to staff the budget and the context within the organizational financials.

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Contribute to the success of the UW Health by providing leadership, direction and coordination of operations, finances and human resources for area of responsibility.

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Manage and direct all activities within area of responsibility.

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Continually assesses all services, identifies problems, utilizes data to analyze and propose innovative approaches for solutions.

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Maintain records related to operations and services that are complete, accurate, available, and in compliance with all legal, regulatory, and policy requirements.

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Engages staff and other stakeholders in continuous improvement of systems and processes; manages resources for staff participation in improvement work activities.

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Ensures effective facilitation of improvement teams and development of leadership skills to ensure overall effectiveness of the meetings.

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Organizes and prioritizes time and resources to manage efficiency.  Appropriately delegates.

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Remains current of new trends and best practices and incorporates into the department's practices and programs.

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Articulates and enforces standards for quality/safe patient care

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Develops and implements innovative systems and processes that improve staff and patient quality and safety

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Demonstrates achievable and measurable results and develop action plans for improvement

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Initiates, monitors and enforces regulatory requirements

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Holds self and others accountable to policy, standards and commitments and provides timely follow through on questions and concerns.

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Ensures development of department initiatives to improve patient satisfaction and family centered care.

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Develops and implements clinical outcome measures for quality improvement, cost and complication reduction, and the implementation of evidence-based medicine.

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Incorporates the use of evidence based practice and appreciative enquiry into program development and improvement activities

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Actively listens to staff ideas and concerns, assesses others communication styles and adapts to them.

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Effectively facilitates meetings at the department and organizational level.

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Creates bi-directional systems that effectively communicate information and data, utilizing multiple methods.

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Articulates and presents data, information and ideas in a clear and concise manner.

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Communicates opinions and ideas in a nonthreatening and nonjudgmental manner to staff, peers and others.

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Communicates with physicians, academic department leaders, and senior administrators to maintain coordination with other UW Health programs.

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Demonstrates empathy and concern while ensuring department goals are met. 

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Manages the complex interdepartmental and interdisciplinary relationships to assure collaboration and effective/efficient operations within the department.

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Creates an environment that encourages diverse opinion, recognizes differences and incorporates into process and services.

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Exhibits awareness of personal attitudes and beliefs, recognizing its effect on response to others.

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Creates a culture and systems for recognizing and rewarding staff.

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Creates and maintains a satisfying workplace that fosters professional growth and job satisfaction for all members of the healthcare team.

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Interviews to select top talent, matching department needs with appropriate skill sets.

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Develops and implements recruitment and retention strategies that support a culture of leadership.

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Identifies and addresses own professional growth needs.

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Assesses manager and staff development needs, identifies goals and provides resources.

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Identifies lack of competency in performance and establishes a plan which includes goals, interventions and measures.

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Maintains membership in professional organization(s) to develop knowledge and resources through networking, continuing education, and participation in national, regional, and/or local activities.

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Ensures integration of ethical standards and core values into everyday work activities.

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Provides opportunities to aspiring clinicians and leaders to develop skills to meet career goals.

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Contributes to a learning environment by providing educational and research experiences to students, residents, fellows, and faculty.

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Leads and/or serves on a variety of appropriate internal and external committees to represent the department.

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Serves as a representative of the department to UW Health in order to facilitate the shared interests and relationship between the parties.

As needed, additional responsibilities reasonably within the scope of duties and physical requirements may be assigned.  ALL DUTIES AND REQUIREMENTS MUST BE PERFORMED CONSISTENT WITH THE UW HEALTH PERFORMANCE STANDARDS AND RESPECT FOR PEOPLE COMMITTMENTS.

X

Non-Clinical

JOB REQUIREMENTS

Master's Degree

in a relevant subject area such as a science or research-based discipline

Required

MD, PharmD, or PhD

Preferred

Clinical research training

Preferred

10 years

of progressively responsible management or leadership level experience in clinical trials

Required

Experience in establishing and managing external partnerships between pharma or contract research organizations and academic health centers

Required

Experience leading clinical operations in a pharma or contract research organization

Preferred

Experience working in a large academic or complex health organization

Preferred

Certification in clinical research

Preferred

LICENSE, CERTIFICATIONS, AND REGISTRATIONS MUST BE MAINTAINED PER UW HEALTH POLICY. 

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Expertise in clinical trials standards and process.

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Expertise in regulatory and quality processes related to clinical trials.

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Excellent communication and interpersonal skills to include the ability to negotiate and resolve conflicts and build teams.

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Demonstrated creativity and flexibility.

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Ability to operate in high-pressure situations.

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Excellent organizational skills.

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Demonstrated innovative approach to problem resolution.

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Ability to work collaboratively across UW Health entities and disciplines. Demonstrated commitment to patient- and family centered care.

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Broad knowledge of modern health care administration practices and principles within a managed care environment and/or an academic medical center.

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Effective analytical ability in order to develop and analyze options, recommend solutions to and solve complex problems and issues.

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Demonstrated effective managerial and administrative leadership of clinical operations

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Knowledge of principles and techniques used in negotiation as applied to service contracts and equipment purchasing.

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Effective organizational, planning and project management abilities.

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Experience in financial and programmatic presentations.

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Ability to function independently and deal with multiple, simultaneous projects.

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Ability to recognize personal strengths and weaknesses and develop goals for professional growth and achievement.

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Ability to demonstrate a commitment to quality and excellence.

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Effective leadership abilities:

• Ability to implement change in a positive, sensitive and forward- thinking manner
• Planning and problem solving
• Developing goals and objectives, and establishing priorities
• Inspires confidence, appropriate risk taking and achievement of high standards
• Good judgment and ability to act decisively at the right time
• Ability to persuade others and develop consensus
• Effective communication skills both in written and verbal presentation with a communication style that is open and foster trust, credibility and understanding.
• Ability to effectively collaborative and promote teamwork
• Ability to ensure a high level of customer satisfaction including employees, patients, visitors, faculty, referring physicians and external stakeholders
• Ability to create win/win solutions and relationships

PHYSICAL REQUIREMENTS/WORKING CONDITIONS

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Sedentary: Ability to lift up to 10 pounds maximum and occasionally lifting and/or carrying such articles as dockets, ledgers and small tools. Although a sedentary job is defined as one, which involves sitting, a certain amount of walking and standing is often necessary in carrying out job duties. Jobs are sedentary if walking and standing are required only occasionally and other sedentary criteria are met.

Up to 10#

Negligible

Negligible

☐

Light: Ability to lift up to 20 pounds maximum with frequent lifting and/or carrying of objects weighing up to 10 pounds. Even though the weight lifted may only be negligible amount, a job is in this category when it requires walking or standing to a significant degree.

up to 20#

Up to 10# or requires significant walking or standing or requires pushing/pulling of arm/leg controls.

Negligible or constant push/pull of items of negligible weight

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Medium: Ability to lift up to 50 pounds maximum with frequent lifting and/or carrying objects weighing up to 25 pounds.

20-50#

10-25#

Negligible-10#

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Heavy: Ability to lift up to 100 pounds maximum with frequent lifting and/or carrying objects weighing up to 50 pounds.

50-100#

25-50#

10-20#

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Very Heavy: Ability to lift over 100 pounds with frequent lifting and/or carrying objects weighing over 50 pounds.

Over 100#

Over 50#

Over 20#

Other - list any other physical requirements or bona fide occupational qualifications not indicated above:

Over 50 lbs.

UW Health does not require, nor does it expect that its employees lift more than 50 lbs unassisted. Objects in excess of 50 lbs should be lifted or moved with mechanical means or through a team lift. Employees in patient care areas are expected to utilize mechanical lifts and adhere to the "Use of Mechanical Lifts (Liko)" policy in the Patient Services Policy and Procedure Manual.

Note: The purpose of this document is to describe the general nature and level of work performed by personnel so classified; it is not intended to serve as an inclusive list of all responsibilities associated with this position.

THE EMPLOYEE MUST BE ABLE TO COMPLETE ALL PHYSICAL REQUIREMENTS OF THE JOB WITH OR WITHOUT AN APPROVED ACCOMODATION. Note: The purpose of this document is to describe the general nature and level of work performed by personnel so classified; it is not intended to serve as an inclusive list of all responsibilities associated with this position.