Manager, Clinical Research

JOB SUMMARY

Clinical Research Managers (licensed or non-licensed) focus primarily on planning, developing, managing, and directing an overall clinical research program within a division, center, or department. They work within as well as outside the University, soliciting clinical research opportunities, promoting the University's resource capabilities, and managing affiliate institutions. Clinical Research Managers may be licensed or unlicensed depending on the specific needs of the trials which they support. They oversee the hiring, management, professional development and performance evaluation, as well as resource management of their team. They participate in developing clinical research policies and management of the research staff. Clinical Research Managers also have significant responsibility for the overall conduct, organization and success of clinical research activities. They manage departmental programs and projects. In addition to managing complex clinical trials programs, Clinical Research Managers direct the work of a sufficient number of employees so that a significant amount of their time is spent supervising teams.

• Manage resources needed to conduct clinical research effectively including: department or division research budgets, clinical research space, staffing availability and access to appropriate technology needed to conduct clinical research.

• Conduct strategic planning and analysis of research portfolios, in conjunction with department management and Principal Investigators.

• Prepare reports for research leadership highlighting division or department research activities, accomplishments and potential areas for improvement.

• Participate in development of clinical research policies and procedures at a division, department and institutional level.

• Work within and outside the University in the pursuit of clinical research business development and/or collaborations with other research institutions promoting the University's resources capabilities.

• Oversee the financial management of clinical research projects, including budget development and billing reconciliation, as well as the management of PI research accounts.

• Assist with the development and submission grant proposals and with writing of clinical trial protocols.

• Assist with the preparation of abstracts and manuscripts.

• Oversee and/or directly manage all clinical research staff this would include: hiring, training, staff scheduling, workload assignments, compensation management, professional development and performance management.

• May perform all duties of a Senior Clinical Research Coordinator, as needed, but primary focus of this role is management of clinical trial enterprise.

• Implement protocols and on-going quality review of clinical research.

• In addition to the above job responsibilities, other duties may be assigned.

Job Description

Analysis:Analyzes processes and creates deliverables to provide information and recommendations for improvements.

• Breaks down problems and issues into sub-components and assesses the costs, benefits, and risks of various options.

• Is able to select and recommend the best solution based on a thorough examination of all considerations.

• Is able to explain and justify actions in a systematic and logical fashion.

Communication:Shares and receives information using clear oral, written, and interpersonal communication skills.

• Demonstrates effective written and oral communication skills.

• Actively listens, provides constructive feedback, and demonstrates respect for differing views.

• Tailors communications to diverse audiences.

Quality Improvement:Demonstrates involvement in the unit's annual and/or periodic assessment efforts, including efforts to improve the quality services.

• Understands the value of innovation and quality improvement.

• Improves processes and practices by identifying inefficiencies and redundancies.

• Demonstrates efficiency and quality in one's own work.

Customer Service:Builds relationships and maintains strategic partnerships with key internal and external stakeholders.

• Understands the importance of quality service.

• Is able to adjust and adapt service delivery to diverse customer needs and sensitivities.

• Frequently suggests and implements changes to improve the quality of service.

Financial Management:Manages tasks and resources within the department to achieve quality and meet budget requirements.

• Ensures that financial and material resources are used effectively and efficiently.

• Leverages resources to maximize utility and return on investment (ROI).

• Implements measures to minimize theft, damage, or equipment breakdown.

The incumbent may be asked to perform additional duties as assigned.

QUALIFICATIONS

Education:Bachelor's degree required. Master's or other advanced degree preferred.

Experience: At least 10 years of clinical research experience demonstrating progressive levels of responsibility including but not limited to: management of research finances, clinical trial portfolio oversight, hiring and training research staff, and performance management. Master's or other advanced degree may substitute for one year of clinical research experience.

Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire.