At Boston Children's Hospital, success is measured in patients treated, parents comforted and teams taught. It's in discoveries made, processes perfected, and technology advanced. In major medical breakthroughs and small acts of kindness. And in colleagues who have your back and patients who have your heart. As a teaching hospital of Harvard Medical School, our reach is global and our impact is profound. Join our acclaimed Cardiology Research department and discover how your talents can change lives. Yours included.
The BioinformatianII will be responsible for: Leads day-to-day data management activities for a multicenter randomized clinical trial of immunosuppression therapy in pediatric heart transplant recipients, and related ancillary studies. 2. Designs, develops, tests, validates, and manages a commercially available Web-based EDC system to support study outcomes. 3. 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. 4. Supports clinical research reporting for data review, quality control edit checks, and interim and final analysis. 5. Completes database cleaning and database lock, and assists research biostatisticians with analysis file creation and statistical analyses. 6. Provides educational support and training to investigators and study site coordinators for the development and implementation of research studies. 7. Mentors data management/data entry staff and provides project management support for Heart Center CRP studies. 8. 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. 9. Provides positive and effective customer service and contributes to teamwork within and between departments, divisions, programs and other organizations. 10. Ensures work in the Heart Center CRP is performed in conformance with established hospital, program, federal, and state policies and procedures.
To qualify, you must have:
Advanced degree in Bioinformatics, Informatics, Computer Sciences, Statistics, Biostatistics, Biology, Chemistry, Physics or a closely related field.
Additionally, 3-5 years of experience as a clinical data manager and with developing relational databases for clinical studies using a commercially available EDC system (e.g. Oracle InForm; RAVE; eCOS ; Phase Forward; Medrio) is required.
Completion of a degree in a closely related field and five years of experience, including experience in independent bioinformatics consulting and analysis, assistance with protocol generation and grant writing, and collaboration in scientific writing.
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.
Internal Number: 2794280
About Boston Children's Hospital
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.