Clinical Data Analyst for Clinical Trials

Location: Bethesda, MD
ERPi is currently seeking a full-time Clinical Data Manager for Clinical Trials to provide onsite support at our Bethesda, MD site.

The Role:
ERPi is seeking candidates for the role of Clinical Data Manager for Clinical Trials. This role is an exciting opportunity for a talented college graduate with a strong desire to work with clinical data in a research setting at the nation’s most prestigious clinical research institution – the National Institutes of Health.
The National Heart, Lung, and Blood Institute’s (NHLBI) Division of Intramural Research (DIR) is dedicated to the advancement of detecting, diagnosing, and treating cardiovascular, pulmonary, and hematologic-related diseases in humans. This research is dependent on clinical trials that may result in broad-reaching clinical treatments, impacting the public health of the community. The DIR’s protocol portfolio is comprised of over 100 active Phase 0/I/II/III interventional therapy, observational/natural history, and cardiovascular imaging protocols.The Clinical Data Manager will work as part of a ERPi team under contract to the NHLBI DIR and will be responsible for clinical data management needs of the DIR’s clinical research program, including assignments to specific protocols, research areas, and/or research teams. The Clinical Data Manager will work closely with clinical research teams to meet protocol objectives. The CDM will be responsible for research data-related activities, quality assurance/quality control, data management, and database-related activities throughout a project lifecycle, from start-up to close out. Activities include, but are not limited to:
  • Gather and enter protocol data into databases according to the specific needs of each protocol
  • Develop and structure protocol-specific data management processes
  • Abstract and grade Adverse Events
  • Run ad-hoc reports for Research Teams
  • Prepare data/reports for routine audits from clinical research monitors
  • Prepare data/reports for audits from regulatory agencies and sponsors
  • Participate in the reconciliation of data discrepancies identified in monitoring visits and audits
  • Participate in the clinical research team meetings
  • Assist with monitoring activities
  • Prepare for and assist with site monitoring visits (SMVs)
  • Assist clinical research teams with resolution of monitor queries
  • Prepare responses to SMV report data queries
  • Assist with quality assurance
  • Support database related activities
 
Required Skills and Experience:
  • 1-2 years experience preferred, however recent college graduate with a bachelors degree in a data-management field is acceptable
  • Bachelor’s degree in a data-management related field
  • Citizen or permanent resident with ability to obtain a Public Trust clearance
 

Desired Skills and Experience:
  • Experience in a clinical research setting preferred
  • Passion for working with data in a clinical research setting
  • Customer service orientation
  • Attention to detail
  • Excellent quantitative, verbal and written communication skills
  • Ability to work in a dynamic, result-driven environment
 
Clearance: Public Trust
 
ABOUT ERPi:
ERPi, a Service-Disabled Veteran Owned Small Business (SVDOSB) specializing in management consulting for the federal government (www.erpi.net).  ERPi is undergoing a period of significant growth and offers talented candidates a chance to perform project management, strategic planning, process improvement, quality management, data analysis, and human capital planning on some of the Federal government’s largest and most complex business challenges. Our work environment is highly entrepreneurial and is staffed with some of the brightest and most capable technical and management consultants in the industry.   ERPi’s compensation and benefits plan are designed to attract and retain the industry’s most capable professionals and executives. We offer tuition reimbursement for selected graduate schools, 401(k) profit sharing, awards to recognize exceptional performance immediately, customized health plans, and charitable donation matching, in addition to competitive base salaries.
 
EEO Statement:
It has been and will continue to be a fundamental policy of ERPi not to discriminate on the basis of race, color, religion, sex, gender, sexual orientation, gender identity or expression, pregnancy, parental status, marital status, citizenship, national origin, age, disability, genetic information, military status, veteran status, or any other protected category with respect to recruitment, hiring, training, promotion, and other terms and conditions of employment.
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