Clinical Research Manager III-Translational Neuroscience Center

The Rosamund Stone Zander Translational Neuroscience Center (RSZ TNC) is seeking a dynamic and innovative Clinical Research Manager III to join our Clinical Research Operations (CRO) team. The RSZ TNC strives to improve the lives of all children with neurodevelopmental disorders by fostering timely and efficient translational research. Working with CRO leadership, the Clinical Research Manager will manage the daily operations of this multidisciplinary research program, which includes guiding the creation and oversight of various programs and teams to reach the Center’s goals and objectives. Under minimal supervision, the Manager will work with the CRO Director in planning, implementing, and overseeing initiatives within the program.
This Clinical Research Manager III will be responsible for:

• Manages daily operations for the multidisciplinary program including assisting CRO Director with oversight of clinical research and regulatory teams. Assists with matters pertaining to administrative procedures, budgets, and personnel either through direct action, advice or as liaison with other managers as appropriate.
• Manages clinical research studies at BCH or other sites.
• Manages clinical research personnel in the department, including hiring, supervision, promotions, pay increases and the performance management process.
• In collaboration with senior management, assists in establishing departmental/division policies and procedures for clinical research.
  • Helps initiate evaluation and implementation of departmental/division policies, procedures, and systems. Reviews and revises periodically to ensure no changes are necessary.
  • Serves as resource for resolution of administrative questions/issues/problems.
• Collaborates and consults with investigators and their staff on the design, development, and conduct of clinical research studies, as well as best practices.
• Provides consultation to investigators and study teams regarding IRB, FDA and other regulatory submissions.
• Alongside Directors, Chiefs and other senior management, assists in development, execution, and monitoring of BCH goals and strategic priorities.
• May work with study investigators and statisticians to plan analyses, clean and verify data and facilitate preparation of datasets for analyses.
• Provides oversight of processes and policies of the RSZ TNC Clinical Research Unit.
• Collaborates with scientific staff in writing grants.
• Develops curriculum, conducts lectures, and directs courses as part of educational efforts to train clinical investigators and study staff in clinical research regulations and best practices. Mentors Clinical Research staff.
• May assist with design and development of data management and data monitoring tools and procedures. May supervise data management staff.
• Assists CRO Leadership and Principal Investigators in the development of the study budgets and responsible for monitoring the budgets.
• Ensures work is performed in conformance with established hospital, program, federal, and state regulations, policies and procedures. Manages staff Performance Reviews.
• Where applicable, assists with hospital, state and federal regulatory policies and procedures.

In order to qualify, you must have:

• A Bachelor’s Degree with 8 years of prior work expereince or a Master’s Degree and 6 years of relevant work expereince.
• Analytical skills to gather and interpret data in which the information or problems are moderately complex-to-complex.
• Well-developed communication skills in order to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions.
• Advanced writing skills.
• Knowledge of the principles and procedures of clinical research.
• Knowledge of federal, state and/or community funding sources and mechanisms.