Manager, Clinical Trials

Location
Duarte, California
Salary
Competitive
Posted
August 13 2021
Ref
10012578
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Healthcare/Hospital
About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary

The Clinical Trials Manager (CTM) provides consistent leadership and general oversight of the daily activities of the Portfolio Supervisors and the disease teams s/he support, to ensure competent and standardized practices that are compliant with all institutional and regulatory requirements. The CTM supports research operations strategic priorities to enhance interdepartmental communication and collaboration and assist in the development of best practices and tools for protocol execution, management and oversight as well as ensure, protocol compliance, quality data collection and compliance with Service Level Agreements (SLAs). The candidate has a significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while maintaining local regulatory and compliance requirements. S/he make decisions independently and oversee important activities relevant to clinical research activities at COH with the support, oversight and supervision of the Senior Director, Clinical Trials Office.

The candidate requires a strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously. S/he needs strong leadership skills (scientific and business) and ability to coordinate and lead teams to high performance. The candidate must work to build and maintain relationships with investigators and other external partners and promote COH's reputation. The candidate is accountable for performance and compliance for assigned protocols compliance with ICH/GCP regulations, institutional policies and procedures, quality standards and adverse event reporting requirements internally and externally. The candidate is the point of contact for assigned protocols and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet institutional commitments for assigned protocols. S/he is responsible for quality and compliance in assigned protocols managed under the portfolio supervisors. The CTM is responsible for collaboration with functional outsourced vendors, investigators, other external partners.

It is expected that the CTM will collaborate internally under general direction from the Senior Director of Clinical Trials Office and will be responsible for the independent management of the assigned clinical trials and research projects. The CTM also serves as a subject matter expert and provides training and oversight to the portfolio supervisors to determine the feasibility and value of endorsed clinical trials, and successful management and execution of all aspects of every clinical trial. The Clinical Trials Manager will be responsible for managing the volume of the studies under his/her purview and working with the portfolio supervisor to resource research staff to each study as appropriate.

Further, s/he will assist the Senior Director in the long term planning for the Clinical Trials Office, in addition to the management of the budgets of each of the studies conducted by the trams that s/he supervises. The CTM is expected to work closely with the clinical trials billing team, in addition to other departments, such as Office of Sponsored Research, Office of Shared Resources, the Institutional Review Board, etc.

The Clinical Trials Manager will also be expected to facilitate communications and act as a liaison between the department and outside company sponsors, such as pharmaceutical and biotechnology companies. Additionally, the incumbent will be responsible for overseeing clinical trials or studies involving several different clinical sites. This position requires a high level of expertise and judgment, analysis, and to assist with extensive management demands. Requires independent decision making to prioritize requests and strong organizational skills to develop administrative systems and procedures. Also expected to provide reports on study related financial expenses and income. Ensures that the department is following organizational and federal rules, policies, and regulations regarding clinical research.

Essential Functions:

Planning and Goal Setting
  • Update and enhance the protocol acuity scoring system.
  • Create and implement policies and procedures to ensure work standardization.
  • Utilize rounding boards and staff huddles to support Organizational and CTO goals.
  • Build and sustain relationships with internal and external stakeholders.
  • Support the strategic plan for the organization and for clinical research.
  • Support departmental implementation of new technology (OnCore and EPIC) and services.
  • Retrieve and deliver pertinent reports to leadership as requested. Effectively communicate (written & oral) across the organization.
  • Serve on working groups to enable City of Hope to meet its strategic goals.

Quality Research Oversight
  • Responsible for ensuring protocol compliance by staff and providing recommendations for corrective action when necessary.
  • Provide back-up support as needed for other CTMs and Portfolio Supervisors.
  • Meet regularly with disease program leaders, investigators and CTO Leadership to provide necessary updates.
  • Communicate and escalate unresolved issues at the appropriate time to the appropriate level of management.
  • Identify and initiate improvements, tools, processes, and forms to enhance the efficiency and the quality of work.
  • Lead the preparation for external audits in collaboration with Research Quality Monitoring.
  • Assist in the review of audited protocols for adherence work with the research team to construct responses to the audit report.
  • Meet with internal and external monitors to communicate any issues or challenges and develop corrective action plans as needed.
  • Provides input in the development of departmental Policies and Procedures.
  • Collaborates with CTO Leadership to lead, manage and document performance improvement projects.
  • Develop and manage standard work in identified Subject Matter Expert (SME) area.

Personnel Management
  • Support efforts to recruit and maintain an adequate number of competent staff to conduct clinical research in compliance with all regulatory, institutional and departmental requirements.
  • In collaboration with CTO Leadership, develop, maintain and monitor staffing plan for assigned teams.
  • Monitor time and effort tracking reports on a periodic basis and review with Portfolio Supervisor as needed.
  • Collaborate with human resources to provide counseling or performance improvement of staff as needed.
  • Manage and lead staff to develop collaborative working relationships within the department and with other departments as applicable.
  • Attends all pertinent departmental COH and Working Group meetings.

Fiscal and Budget
  • Provide financial input for their portfolios in the quarterly and annual budget preparations.
  • Collaborate with CTO Leadership to identify disease team needs on a monthly as well as annual basis.
  • Develop, manage and report on Disease Team portfolio measures.
  • Develops quarterly and annual staffing plan in collaboration with CTO Leadership.
  • Identifies and communicates opportunities for improved efficiency and/or cost saving within the department.
  • Provide documentation to support the purchase of equipment, supplies and/or for department repairs.
  • Provide input and support to CTO and Research Operations Leadership in the development of new programs or services or disease teams.
  • Participates in operational and feasibility assessments performed within the disease programs.

Disease Team Management
  • Work in conjunction with the disease team program lead physicians, Principal Investigators, Clinical Research Nurse Managers and CTO Leadership to accomplish goals, projects and research initiatives for assigned disease teams
  • Collaborates across multidisciplinary teams
  • Provides guidance, direction and management to Portfolio Supervisor regarding disease team meetings (e.g., Protocol Priority List, create agendas, minutes, coordinate speakers, scheduling, etc.)
  • Develops corrective action plans (CAPAs) as needed and ensure adherence to them through training and monitoring
  • Develops working relationships with study sponsors for future collaborations
  • Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.

Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality. Performs other related duties as assigned or requested.

Basic education, experience and certification required for consideration:
  • Bachelor's Degree.
  • Seven or more years' experience as a Clinical Research Coordinator with 2 or more years supervisory experience.
  • CCRP certification.

Preferred education experience and skills:
  • Master's Degree.
  • Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA) certification.

Skills/Abilities:
  • Strong verbal and written communication skills.
  • Knowledge of Good Clinical Practice, Human Subject Protection, clinical trial design, regulatory processes, and clinical development process.
  • Ability to collaborate with internal and external stakeholders.
  • Excellent interpersonal skills.
  • Microsoft applications including word, excel and PowerPoint.

Reporting Relationships:
  • The position directly supervises: Portfolio Supervisors.
  • The position indirectly supervises: Research Coordinators, Project Coordinators, Biospecimen Coordinators.

City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability. #LI-GD

  • Posting Date: Sep 20, 2021
  • Job Field: Clinical Research
  • Employee Status: Regular
  • Shift: Day Job

Similar jobs

Similar jobs