Clinical Data Manager

Employer
Medical Science & Computing, LLC (MSC)
Location
Bethesda, MD
Posted
Sep 15, 2020
Closes
Sep 20, 2020
Ref
1212559169
Hours
Full Time
OverviewWe blend deep domain expertise in health IT, life sciences, public safety, and grants management with advanced technologies to help Federal agencies solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to cultivate a culture of innovation, customer success, and employee growth.Duties & ResponsibilitiesMSC is searching for a Clinical Data Manager to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is on-site in Bethesda, Maryland.Oversee sponsor Clinical Data Management project timelines on multiple complex studies or programs.Provide technical oversight of service providers performing core data management functions including CRF/edit check development, user acceptance testing, data cleaning, listings review, and database lock procedures.Responsible for the oversight of clinical data management study deliverables, evaluates and mitigates risks across programs.Assess the quality of the statistical programming processes through techniques including but not limited to good documentation code review, and testing.Conduct data reviews.Review the development of database specifications, validation plans, and data management plans; ensuring alignment with case report forms, protocol, and safety data standards.Provide input on the clinical data management system enhancements including performing UAT (User Acceptance Testing)Participate in cross-functional process initiatives.RequirementsBachelor's degree in Life Sciences, Computer Science or a related scientific field required. Master's degree, Certified Clinical Data Manager (CCDM) or related graduate certification preferred.Minimum of four (5) years of clinical data management experience is required.Experience managing clinical study data using Electronic Data Capture (EDC) software.Prior experience in database development required.Experienced in developing study documents, specifically case report forms (CRFs), edit check specifications and data management platforms (DMPs).Familiar with the multiple phases of clinical trial development. Knowledge of GCP, ICH and FDA regulations and guidelines a plus.Excellent computer skills and proficient in Microsoft Office Suite and Adobe products. Experience with statistical software a plus.Strong verbal and written communication skills. Demonstrated ability to communicate with non-data focused people is a plus. Medical Science & Computing (MSC), a Dovel company, is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.Job SummaryJob ID: 2020-4083# of Openings: 1Job Location(s): US-MD-BethesdaPosted Date: 1 month ago(8/20/2020 10:44 AM)Category: Science

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