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Clincial Data Manager

MSC


Location:
Bethesda, MD 20814
Date:
10/15/2020
2020-10-152020-11-14
Categories:
  • Healthcare
  • Management
  • Biotechnology / Science
  • Government
  • Facilities
MSC
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Job Details

Overview

Medical Science & Computing (MSC), a Dovel company, is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.

 

We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!

 

Duties & Responsibilities

MSC 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.

 

  • Coordinate development of a core data management resource.
  • Develop data management training and support resources.
  • Establish and oversee quality management processes.
  • Train site staff in data entry.
  • Create and manage data management workflows and project timelines to track progress of data management activities.
  • Oversee and participate in coordination of core clinical trial data tasks including: Case Report Form (CRF) development, processing intake of CRFs, data entry of CRFs into Clinical Data Management System (CDMS), development of edit checks and generation and resolution of data queries, and interim data reports.
  • Establish strong communication pathways with the data operation team, project managers, statistical support and other internal and external stake holders.
  • Serve as the escalation point-of-contact for unresolved data issues.
  • Consult about data management facilities and staffing for special projects.

Requirements

  • Bachelors Degree in health and/or healthcare informatics, clinical, biological or mathematical sciences or related field or equivalent experience.
  • Minimum of eight (8) years direct data management experience with at least three (3) years as a clinical data management project lead.
  • Previous experience managing the delivery of multiple projects through the full data management life cycle.
  • Thorough knowledge of the data management process (e.g., serious adverse event reconciliation, management of local laboratory data) and knowledge of data management operating procedures.
  • Knowledge of clinical research regulations including Good Clinical Practices and relevant regulatory guidelines.
  • Working knowledge of clinical research operations, clinical trials, medical terminology, and/or pharmacology.
  • PMP certification and/or familiarity with REDCap, SAS and R 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.

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