|Location||Wisconsin or Illinois, Milwaukee, Wisconsin|
|Date Posted||October 30, 2020|
|Address||1020 North 12 th Street|
As the Manager Clinical Trials Business Services, you will manage research business operations from start to finish, assuring quality and compliant patient-centered research across the enterprise. Manage staff through the analysis and negotiation of research budgets/contracts. Assure quality management of research services in an efficient, effective and fiscally sound manner, consistent with prevailing policies, regulations, and standard operating procedures. Lead strategic clinical trial business initiatives to continuously improve processes and communications and provide an operationally efficient system. Coordinate research business operations in a manner that maximizes financial return, timeliness and effectiveness while minimizing risk and exposure. Serve as research institute’s liaison to corporate functions for communications and issues regarding previous, current and potential studies.
This role can be based in Wisconsin or Illinois.
- Leads a team in the execution of research business operations that is highly competent, cross-trained, motivated and has clear direction, stated objectives and measurable goals. Ensures high levels of customer service to all stakeholders.
- Collaborates with research committees and managers on selection of studies. Serves as connection point between researchers and corporate functions to ensure quality and compliant research business operations.
- Manages all study agreements originating at industry or non-federal granting agencies throughout the study lifecycle. Administers flow of new and amended contracts through approval process, prioritizing case load and ensuring timely follow-up on status. Provides continuous process improvement to ensure quality, compliance and efficiency in conjunction with industry-competitive timelines for contract approvals. Builds key partnerships and initiates master agreements with select sponsors.
- Oversees all study budget development and negotiation with sponsors and communication with all internal stakeholders regarding study. Collaborates with billing and finance to identify ways to compliantly maximize revenue on trials within fair market value guidelines. Partners with research billing to ensure compliant analysis and harmonization of trial documents.
- Responsible for study invoicing and collection from sponsors according to the contract. Monitors all business operations and financial performance through close of the study. Partners with billing, accounting, and finance to resolve issues/discrepancies related to study financial performance.
- Develops and maintains metrics on effectiveness, efficiency, quality, and value for continual assessment of research business operations. Provides research leadership regular updates on the status and performance of research business operations.
- Oversees research service agreement development and negotiations with independent physians/facilities Responsible for ensuring relationship with independent physicians/facilitiesis set up in compliance with all laws, rules, and regulations. Implements processes to ensure billing and financial payment/collections are performed in a timely and compliant manner when working with independent physicians/facilities. Collaborates with purchasing for procurment of devices needed for studies.
- Develops and maintains study processes that utilize and optimize the capabilities of EPIC and clinical trial management system (CTMS) software.
- Maintains an ongoing prioritized requirements list and utilizes it for continuous improvement. Works with internal stakeholders, resources and vendors and coordinates related education and training associated with adoption of improved processes or systems.
- Assists in other projects regarding research business operations as requested.
- Bachelor's Degree in Business, or Bachelor's Degree in Life Science or related field.
- Typically requires 5 years of experience in research budget and contract negotiations. In-depth understanding of research operations with a strong emphasis on business operations associated with clinical trials.
- 1 year of supervisory experience in leading staff, budget accountability, multiple functions and customer service.
- Solid understanding of research contracting and budgeting principles. Demonstrated experience in business operations associated with clinical trials. Understanding of healthcare systems, workflows, processes and roles.
- Creative problem solver with ability to drive decision-making that sustains organizational change through proven project management, organization, and effective leadership style. Ability to influence without direct authority, and make independent decisions using sound judgment. Exceptional ability to develop and lead a diverse team within a broad scope of guidelines, regulations and established policies while communicating key challenges, activities and decisions with senior leadership and other stakeholders.
- Exceptional verbal and written communication skills across all levels and group sizes. Ability to develop and maintain positive and productive working relationships. Skilled at managing multiple, concurrent complex projects and deadlines within a complex corporate system environment. Ability to analyze issues, opportunities, procedures, processes, and information and discern many sources of information and opinions using logic as well as common sense into rationale, defensible, strategic, compliance business decisions and recommendations. Demonstrated proficiency in Microsoft Office.
Flexibility for this Manager to work in either Wisconsin or Illinois. Ability for occasional travel between greater Milwaukee and greater Chicago areas required.
Applicants can send resumes to [email protected]