The Clinical research Manager Manages daily operations for clinical research studies supported by the Heart Center. In particular, a significant portion of this position will focus on a multicenter clinical research registry of pediatric patients with single ventricle anatomy who have undergone a Fontan procedure and cardiac magnetic resonance imaging. Develops and oversees the implementation of best practice guidelines for conducting various clinical research protocols. Collaborates with Principal Investigators and study stakeholders for management of research studies. Manages communication between study staff and internal and external stakeholders. Manages and trains the activities of research staff and conducts Performance Management process. Assist in preparing and monitoring clinical laboratory and budgets, maintenance of equipment and ensures compliance with hospital and governmental regulations.

Principal Duties and Responsibilities

• Leads and manages the work of multiple clinical research projects. Serves as Clinical Research Study / Trial Manager for one or more large, clinical studies.
• Collaborates and consults with investigators and their staff on the design, development, and conduct of clinical research studies and on clinical research best practices.
• Works with study investigators and statisticians to plan analyses, clean and verify data and facilitate preparation of datasets for analyses.
• Collaborates directly with Hospital investigators and scientific staff on developing and writing grants and study protocols.
• Develops curriculum, conducts lectures, and directs courses as part of sponsored educational efforts to train clinical investigators and study staff in clinical research regulations and best practices.
• Leads design and development of data management and data monitoring tools and procedures and supervises data management staff and activities in compliance with GCP and program standards.
• Lead and collaborates with matrix team to design and develop study databases and related products and procedures. Manages Staff's Performance Reviews.
• Ensures work is performed in conformance with established hospital, program, federal, and state policies and procedures.

Requirements:

• Bachelor's degree and a minimum of 10 years of relevant work experience or Master of Science and 6 yrs of relevant work experience.

Please note: During a public health emergency, individuals in this role may be expected to take on additional duties to respond to organizational needs.
Boston Children's Hospital offers competitive compensation and unmatched benefits, including affordable health, vision and dental insurance, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition Reimbursement and discounted rates on T-passes (50% off). Discover your best.

Boston Children's Hospital is an Equal Opportunity / Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, sexual orientation, gender identity, protected veteran status or disability.