MANAGER, CLINICAL RESEARCH

Company: Sutter Bay Hospitals
Location: San Francisco
Posted on: October 29, 2024

Job Description:

We are so glad you are interested in joining Sutter Health! - Organization: CPMC-California Pacific Med Center Pacific Position Overview: Manages and provides operational leadership to all clinical trials staff, and overall clinical trials programs and operations, which may include one or more teams performing related work. Plans, organizes, and directs 24/7 operations and resources to ensure effective and efficient delivery of services and/or achievement of business results. Establishes protocols and practices, ensuring compliance with department, affiliate, operating unit, and/or system standards, policies and procedures and applicable TJC GCP, ICH and FDA standards and/or laws and regulations. Takes a strategic and tactical approach in identifying best practices and standardizing workflows/processes, and developing plans of action to implement changes. Establishes and manages capital and operational budgets to achieve financial targets via effective utilization of personnel, resources and supplies. Develops and maintains a solid partnership with internal (investigators, supervisors, clinical research coordinators) and external teams (industry sponsors, federal agencies and private foundations) to ensure smooth and efficient clinical trials. Provides guidance and/or direct intervention in resolving challenging or complex situations. Job Description: These Principal Accountabilities, Requirements and Qualifications are not exhaustive, but are merely the most descriptive of the current job. Management reserves the right to revise the job description or require that other tasks be performed when the circumstances of the job change (for example, emergencies, staff changes, workload, or technical development).

JOB ACCOUNTABILITIES:

OPERATIONS
--- Plans, organizes, and directs 24/7 operations and resources clinical research staff to ensure effective and efficient delivery of services, and/or achievement of business results.
--- Establishes protocols and practices, ensuring compliance with department, affiliate, operating unit, and/or system standards, policies and procedures and applicable TJC GCP, ICH and FDA standards and/or laws and regulations, including regulatory requirements of clinical trials and tenants of "Good Clinical Practice".
--- Takes a strategic and tactical approach in identifying best practices and standardizing workflows/processes and developing plans of action to implement changes.
--- Establishes and communicates priorities and operational objectives to ensure business results are achieved.
--- Makes rounds with clinical trials staff to listen to concerns/issues and ensure staff have appropriate tools and resources.
--- Directs or leads continuous improvement efforts using Lean or other process improvement methods and concepts.
--- Ensures appropriate records are maintained for documentation and audit purposes.
--- Promotes efficient and effective communications between departments and/or business teams to improve and standardize work flows
--- Identifies and works to remove barriers that may hinder the achievement of process/productivity improvement and efficiency.
--- Provides guidance and direct intervention in resolving challenging or complex situations.
--- Develops, implements and/or ensures corrective action plans are implemented to address or minimize operational risk.
--- Manages vendor contracts to ensure terms and conditions follow operating unit and/or system protocols.
--- Keeps leadership informed of operations and escalates complex issues requiring higher level intervention.
--- Develops and maintains a solid partnership with internal and external peers, leaders, and/or local/state/federal agencies to facilitate and collaborate on initiatives or issues resolution.

PEOPLE
--- Provides and fosters an inclusive work environment that encourages staff engagement and collaboration, establishing a culture of teamwork.
--- Supervises clinical trials staff, makes hiring and termination decisions, and reviews and approves timekeeping records.
--- Establishes expectations with all direct reports, holds individuals and work teams accountable, and ensures job descriptions accurately reflect job responsibilities and expectations.
--- Evaluates staff performance and makes/recommends associated merit increase. Provides constructive feedback, coaching and counseling. Implements disciplinary actions and/or performance improvement plans to achieve desired performance. May work with leadership when major disciplinary action is necessary or in consultation with Human Resources.
--- Provides opportunities for career development, role expansion, and cross-training.
--- Monitors department training and orientation plans, ensuring staff meets competency requirements and participates in appropriate education and training programs.
--- Conducts staff meetings for informative and educational purposes.
--- Responds timely to alleged violations of policies, procedures, regulations and standards of conduct by evaluating or initiating investigative procedures. May consult with Human Resources or Compliance to determine appropriate course of action.
--- Ensures staff maintains current and appropriate professional credentials.

FINANCIAL MANAGEMENT
Establishes and manages capital and operational budgets to achieve financial targets via effective utilization of personnel, resources and supplies.
--- Monitors department productivity, ensuring operational challenges are addressed timely.
Reviews financial reports and develops and implements corrective action plans to address unfavorable variances.
Reviews and approves employee expense reimbursements, and billing statements from vendors according to established protocol.

STRATEGY/PLANNING
--- Leads departmental goal setting process and provides roadmap for accomplishing goals. Monitors progress, developing action plans to address issues and challenges.
--- Collaborates with physicians to identify and open trials with scientific merit, strong potential to enroll patients, and economic viability.
--- Communicates affiliate, operating unit and system goals to staff, helping staff understand impact on operations and resources.
--- Develops plan of action to address current and future resource needs in order to meet service and/or operational demands and objectives.
--- Identifies process improvement opportunities, and initiates action plan to meet short/long term operational objectives or service level agreements (SLAs).
--- Develops metrics and methods for measuring outcomes against relevant internal and external benchmarks; assists in the identification of criteria and effective qualitative/quantitative measurement tools.
--- Develops and implements a plan to increase enrollment into clinical trials.
--- Prepares reports and/or analyses, identifying operational trends and recurrent issues, and recommends and implements course of action.
--- May participate in and/or facilitate ad-hoc committees and task forces to collaborate on or support new or ongoing initiatives.
--- During peak periods, may perform tasks to assist team in achieving business results or SLAs.
--- May assume responsibilities of one-up leader role during his/her absence.
--- Performs other duties as assigned.

EDUCATION
Equivalent experience will be accepted in lieu of the required degree or diploma.

Bachelor's: Business Administration, Healthcare or related field or equivalent education/experience

CERTIFICATION & LICENSURE

BLS-Basic Life Support Healthcare Provider

TYPICAL EXPERIENCE:
8 years recent relevant experience

SKILLS AND KNOWLEDGE:

Demonstrated knowledge in compliance with external guidelines, Good Clinical Practice, statutory and accreditation parameters including JCAHO, FDA and other laws & regulations.

Knowledge of medical procedures and medical terminology, as well as well-developed clinical-assessment skills.

Demonstrated leadership skills, including team building, and coaching/mentoring with the ability to motivate and engage others.

Thorough understanding of operations and workflows and how department's process/workflow impacts other department operations.

Demonstrates understanding of business and operational requirements.

Demonstrates ability to develop and manage a budget.

Demonstrates tactical and analytical thinking and planning skills, and is able to develop plan to accomplish objectives, identify obstacles and resolve operational issues.

Knowledge of emerging treads and how it impacts operations.

Ability to build and establish effective working partnership with employees, peers and/or leaders to achieve business objectives.

Demonstrates ability to handle confidential and sensitive issues.

Verbal and written communication, and interpersonal skills.

Ability to handle difficult circumstances and make sound business decisions with little direction.

Demonstrates ability to work in a dynamic and fast-paced environment with changing business priorities.

Organizational and time management skills, with the ability to prioritize multiple projects while delivering quality service and achieving business results.

Demonstrates a customer service focus in all decisions and actions.

Demonstrates ability to work/interact with a diverse population while respecting cultural and linguistic differences and fostering an inclusive work environment.

Working knowledge of wage and hour laws.

Knowledge of computer applications, such as Microsoft Office Suite (Word, Excel, Access, and PowerPoint).

PHYSICAL ACTIVITIES AND REQUIREMENTS:

See required physical demands, mental components, visual activities & working conditions at the following link: Job Requirements Job Shift: Days Schedule: Full Time Shift Hours: 8 Days of the Week: Monday - Friday Weekend Requirements: None Benefits: Yes Unions: No This position is work from home eligible. Position Status: Exempt Weekly Hours: 40 Employee Status: Regular Number of Openings: 1 Sutter Health is an equal opportunity employer EOE/M/F/Disability/Veterans. Pay Range is $66.99 to $100.49 / hour The salary range for this role may vary above or below the posted range as determined by location. This range has not been adjusted for any specific geographic differential applicable by area where the position may be filled. Compensation takes into account several factors including but not limited to a candidate's experience, education, skills, licensure and certifications, department equity, training and organizational needs. Base pay is just one piece of the total rewards program offered by Sutter Health. Eligible roles also qualify for a comprehensive benefits package.

Keywords: Sutter Bay Hospitals, West Sacramento , MANAGER, CLINICAL RESEARCH, Healthcare , San Francisco, California