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Our research enterprise is the largest pediatric research program in the world, based on extramural research funding, characterized by innovation in the prevention, diagnosis and treatment of childhood disease as well as enhances the institution's reputation in both science and pediatric healthcare. The Heart Center Clinical Research Program (CRP) is seeking an experienced Clinical Data Manager for a first-of-its-kind multicenter randomized clinical trial of immunosuppression therapy in pediatric heart transplant recipients, and related ancillary studies.
Leads day-to-day data management activities for multicenter trials and studies supported by the Heart Center CRP.
Designs, develops, tests, validates, and manages a commercially available Web-based EDC system to support study outcomes.
Writes and implements data management plans (DMP), data entry guidelines, and data completion guidelines in compliance with Standard Operating Procedures (SOPs), ICH-GCP guidelines, and FDA requirements.
Supports clinical research reporting for data review, quality control edit checks, and interim and final analysis.
Completes database cleaning and database lock, and assists research biostatisticians with analysis file creation and statistical analyses.
Provides educational support and training to investigators and study site coordinators for the development and implementation of research studies.
Mentors data management/data entry staff.
Serves as credible expert/leader for data management best practices. Collaborates with Heart Center CRP Scientific Director to establish priorities and strategies for resource development and core goal setting.
Provides positive and effective customer service and contributes to teamwork within and between departments, divisions, programs and outside organizations.
Ensures work in the Heart Center CRP is performed in conformance with established hospital, program, federal, and state policies and procedures.
A Master's degree in health science, public health, epidemiology, bioinformatics or closely related field, including course work in biostatistics or computerized analytic techniques, and 3-5 years of experience as a clinical data manager.
Analytical skills to handle complex clinical research data in an organized, accurate and timely manner.
Proficiency in Oracle InForm in particular and generally a range of data management and statistical software (e.g. SAS, relational clinical data management products, such as Oracle InForm; RAVE; eCOS, Phase Forward; Medrio).
A proven capability for self-directed identification of data queries; attention to detail and accuracy with respect to tracking and resolution of complex analytical data management challenges.
Strong written and oral communication skills.
Knowledge of FDA regulations and ICH GCPs guidelines.
Please note: During a public health emergency, individuals in this role may be expected to take on additional duties to respond to organizational need s.
Boston Children's Hospital offers competitive compensation and unmatched benefits.
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.
Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care. As one of the largest pediatric medical centers in the United States, Children's offers a complete range of health care services for children from birth through 21 years of age.