Senior Manager, Clinical Trials Support Services
City of Hope – Monrovia, CA
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 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.
The Senior Manager of Clinical Trials Support Services (CTSS) oversees processes and staff within a critical department that serves the research community in the negotiation and execution of all Clinical Trial Agreements, Confidentiality Disclosure Agreements, Material Transfer Agreements, Data Use Agreements and other consortium and collaboration agreements and budgeting assessments. The position is directly responsible for the coverage analysis development process and corresponding budget development process involving industry, federal, foundation, and internally funded clinical trials (and their related study amendments). The Senior Manager is expected to provide guidance on the identification of administrative and patient care costs related to clinical trials and will ensure that contract and budget finalization occurs in a timely fashion. S/he will maintain expertise in the clinical trial start-up space, offering strategic and measurable solutions to issues faced by his/her direct reports and those identified by Research Operations leadership.
In this role, the Senior Manager will regularly interact with patient financial services, general counsel, compliance, COH Medical Foundation, research finance, clinical research billing, clinical research content, and clinical data management teams. Furthermore, the role requires maintaining effective partnerships and relationships between Department Chairs, Clinical Research Faculty and research operations leadership.
The position works as an integral part of the existing CTSS team, under the overall direction of the Director of Clinical Trials Administration. While this role naturally provides higher level support to the team’s core responsibilities, the Senior Manager of CTSS is very much expected to work alongside the team to meet goals, objectives, and expectations set by the research community and Research Operations leadership.
Key Responsibilities include:
Provide oversight of the day-to-day operations of the CTSS office. Partner with the Director, Clinical Trials Administration and the Senior Director, Clinical Research Services in determining and enacting the short- and long-term vision for CTSS.
Serve as a subject matter expert in the clinical trials start-up space, especially as it pertains to the OnCore Clinical Trials Management System (CTMS), especially any modules specifically related to CTSS core responsibilities.
Implement the Director’s instructions and keep leadership apprised of important events. Assist the Director in managing higher-level administrative and financial requirements of the department and ensure success in all activities:
Provide updates to regular reports, including performance metrics, staffing and resources, and advise on desirable actions and procedures.
Prepare effective dashboards that can be shared with Disease and Modality Team leaders as well as senior research operations leadership.
Liaise with supporting campus units including, but not limited, to Human Resources, Payroll, Office of Sponsored Research, Research Data and Management Analysis, Corporate Accounting, Clinical Trials Office, Subject Protections Committees, Compliance, Office of Foundation Relations and Facilities and use those contacts to request support and solve problems.
Act as the ‘face’ of CTSS to the clinical community, specific to coverage analysis drafting and budget development processes to both achieve support and address concerns on a regular basis.
Core Working Responsibilities
Directly manage the workload of CTSS Budget Administrators and Coverage Analysts while ensuring alignment with, and indirectly managing, Contract Administrator responsibilities pertaining to finalizing and executing clinical research agreements of various types.
Ensure coverage analyses, budgets, and contracts are developed for all clinical trials, as needed. This includes performing these tasks as a “working manager” when needed and/or as dictated by the Director. Oversee of the process of building complete and accurate clinical trial budgets estimates or “preliminary budgets”
Manage a timely, effective, and efficient turnaround of the coverage analysis, budgeting, and contracting workload, all-inclusive.
Provide oversight and ownership of CTSS-based databases, metrics development, and data accuracy. Use this knowledge to develop and offer solutions to senior leadership for further efficiencies within the typical CTSS workflow.
Assist with removing roadblocks for tasks that have been within the purview of the CTSS office beyond pre-established timelines to ensure quick resolution, and escalation of challenges as needed.
As needed, serve on steering committees or working groups as appointed by the Director and Senior Director.
Keep abreast of COH accounting / billing procedures and directives, and keep the Director informed of same.
Develop, revise, and strategize new policies, procedures, viewpoints, and standard practices in conjunction with all aspects of coverage analysis, budget development, and contract execution as they pertain to clinical research.
Assist with the writing of job descriptions, hiring, on-boarding new staff, layoffs, terminations, evaluations, appointment entry on COH systems, record keeping, and other aspects of personnel management.
Supervise staff training, prioritize and assign work to the department staff, and follow up to ensure accurate and timely completion of work.
Coordinate staff work and assist staff by answering questions and informing them of COH procedures.
Hold regular meetings with departmental personnel to discuss administrative issues and issuing of guidelines for internal procedures. Cascade information as necessary.
Review and approve time sheets (via API) for directly supervised staff.
Liaise with Patient Financial Services to ensure appropriate payment or reimbursement designations are in place based on Institutional compliance decisions, nationally recognized guidelines, or information from denials management reports.
Act as a liaison and core informational resource between COH and any external consulting agencies or contractors providing assistance to CTSS workflows and general processes.
Offer as needed training to any individuals who rely on coverage analysis or budget information to carry out non-CTSS responsibilities.
Provide training to Principal Investigators, Sponsors, Legal counsel, CRO’s, Business Managers, CRA’s, and/or Support Staff on COH policies and procedures regarding clinical trial billing processes.
Provide timeline / general status updates to Investigators, Study Teams, COH Leadership on a weekly basis or as requested.
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 skills required for consideration:
Must have Master’s degree (or higher) in healthcare administration, business, finance, science or related field or MBA/MHA.
Must have 6+ years of healthcare management experience in an academic research or healthcare environment. Progressively responsible management experience is desired.
Must have demonstrated experience in clinical trial budget development, contracting, coverage analysis drafting, and overall financial management.
Must have excellent interpersonal and organizational skills. Excellent communication skills. High level of integrity and honesty in maintaining confidentiality.
Must have OnCore CTMS experience
Must demonstrate professionalism and integrity.
Must demonstrate knowledge of the principles of management and accounting and their use in a research/scientific/medical environment.
Must have ability to analyze complex administrative and financial data, create reports and craft effective solutions to both long- and short-term problems.
Must demonstrate ability to work independently, set own priorities, recognize problems and follow up to ensure effective action is completed.
Mus have excellent oral and written communication skills.
Must be skilled in working collaboratively in a team-oriented environment, recognizing others' expertise and collaborating on final outcomes.
Must demonstrate ability to supervise and motivate professional and administrative support staff, including interviewing, selection, training, performance reviews and disciplinary action.
Must have experience and skill in using standard office software i.e. Microsoft Word, Excel, PowerPoint, Access.
Preferred education experience and skills:
Knowledge of Good Clinical Practice Guidelines, ICH Guidelines, FDA and HIPAA regulations, Medicare policy on Routine Costs in Clinical Trials
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.
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