Clinical Data Manager

MD - Rockville
Oct 10, 2018
Nov 12, 2018
Full Time
Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC.
Job Summary
: Westat is seeking a Clinical Data Manager who will work as part of a ERPi team under contract to the National Heart Lung and Blood Institute (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.

Job Responsibilities:

· 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 and 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 and support database related activities.

Basic Qualifications:

· Bachelor's degree in a data-management related field with 1 year of experience is required. · Must be able to obtain a Public Trust clearance.

Preferred Qualifications:

· Experience in a clinical research setting preferred. · Passion for working with data in a clinical research setting. · Customer service orientation.
The successful candidate must be able to work both independently and in a team environment, demonstrate excellent attention to detail, and have strong quantitative, written and oral communication skills, interpersonal, and organizational skills.
Westat offers competitive benefits with ESOP, 401k, Health, Dental, paid vacation, sick and holiday leave, professional development as well as other benefits.
Any offer of employment may be contingent upon receipt of acceptable results from a post-offer background screening, if required for the position, based on the specific position which may include, for example, identity verification, employment history, or criminal records history.
Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, gender identity, or any other protected status under applicable law.

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