New England Research Institutes (NERI) was founded in 1986 and has grown to become a research organization with a global reputation for high-quality research, innovative thinking, and the use of state-of-the-science tools and techniques. NERI continues to be a leader in public health research, clinical trials management, epidemiology, and state of the art media and dissemination research.
NERI's uninterrupted growth and success has been driven by strong leadership, disciplined attention to scientific integrity, and its ability to attract and retain exceptionally talented staff members. The depth of experience, skill, and expertise that the entire NERI staff brings to each project is what sets NERI apart from other research organizations and is what continues to propel NERI through the 21st century.
We currently have an opening for a full time Clinical Data Manager
PURPOSE of JOB:
This position leads the clinical data management process for individual trials. The Clinical Data Manager possesses sufficient technical and organization skills to work without detailed supervision leading the activities for multiple trials including multi-vendor or global trials. The job requires ability to plan and coordinate the work of other support personnel and judge the quality and quantity of work produced.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Assists or develops data management plan components for study design and database content development including study summary/data flow diagrams, timelines, critical variables list, and data review procedures. Configures the data content collection per the research protocol in the EDC system or peer reviews the configuration for other CDMs. Responsible for eCRF testing, edit check development and configuration, documentation, and user training prior to going live. Per project needs, programs specific reports in the EDC system or using SAS, writes reports specification as required by the project's needs. Assists or develops data transfer agreements components for vendor supplied data.
Develops and implements all data management requirements within a study. Develops complex case report forms (CRF's), complex validations and data collection processes. Interfaces with the study team to ensure that data reporting needs are scheduled and addressed. Coordinates input from project statistician to ensure that Statistical Analysis Plan (SAP) requirements are met. Tracks problems to resolution. Actively contributes to the review of working practices and data management SOPs. Trains site staff on data management systems and processes. Will assist in the development of training and procedures manuals.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with regular and reliable attendance. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Master's in Public Health or Bachelor's degree (B.A./B.S.) in Social or Biological Sciences, computer science or related field and one to three years of directly related data management experience and/or training or equivalent combination of education and experience.
KNOWLEDGE, SKILLS and ABILITIES
Knowledge of electronic data management systems, proficiency with Microsoft Office applications, ability to create queries in SQL is a plus; strong verbal and written communication skills; knowledge of statistical software such as SAS is helpful.
NERI is an Equal Opportunity Employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identify and expression, age, disability, Vietnam era or other eligible veteran status, or any other protected factor.