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Senior Clinical Data Manager - United States  

Company managed [?] Still accepting applications

Posted on : 14 June 2017

Project Description

Description:
  • We are seeking a full-time Senior Clinical Data Manager for our Data Management team. 
  •  This person will provide comprehensive data management expertise and manages end-to-end delivery of data management services. 
  • Responsible for the integrity of the data entered into a company CRF/eCRF and database.
  • Ensures database is complete, accurate and consistent and meets quality standards required by Sponsors and regulatory bodies. 
  • Collaborates and participates in multidisciplinary teams involved in setting up, running and reporting clinical trials. 
  • Responsible for Sponsor contact, project communication and timeline management for all data management functions. 
  • Manages, organizes and processes clinical data using a range of computer applications and database systems and processes (EDC and paper-based) to facilitate collection and cleaning of subject data.
 

Essential Functions:
Leading Studies/Programs – Manages clinical data management activities for assigned studies/programs in accordance with company SOP's, policies and practices. 
QC Functions – Using Edit Checks, Data Listings and other available tools/reports, manage Quality Control of data to ensure accurate, complete data is provided according to study timelines and contract described deliverables.
Management of CRFs – Oversee CRFs from the creation of the blank CRF through delivery of final CRF to sponsor.
Data Cleaning and Delivery – Manage clinical data cleaning and delivery activities up to and including database lock.




Knowledge/Skills/Education/Licenses: 
  • Bachelor degree in Business, Science or related field or a combination of education and relevant data management pharmaceutical industry experience   
  • Minimum 7-10 years data management experience required, 4-5 years of which should be direct CDM Lead experience. 
  • Knowledge of Good Clinical Data Management Practices, CDASH/CDISC, SDTM, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 required 
  • Knowledge of SAS and SQL required 
  • Knowledge of paper, EDC, and hybrid-base data collection and processing, as well as experience with multiple CDMS/e-clinical systems; strong technical skills 
  • Ability to create, review, and revise CDM training materials, SOPs, and process/procedural guidelines 
  • Ability to manage multiple projects/program priorities required 
  • High attention to detail required 
  • Excellent oral and written communication skills required 
  • Excellent organizational and presentation skills required 
  • Proficiency in MS office applications required