Purpose : Assist the lead data manager in database development and data review for clinical trials and patient registry programs in compliance with standard operating procedures, client guidelines, contractual obligations and regulatory agency guidelines
Be responsible and accountable for part of the data management activities within a study
Review clinical trial and patient registry data according to client needs and protocol endpoints under the direction of the Lead CDM
Adheres to established database standards and structures to meet data management and reporting requirements
Review study reports, listings, tables, graphs and other presentations of study data under the direction of the Lead CDM
Assist with development of CRFs and eCRFs in accordance with established standards.
Assists with identifying, developing and implementing data quality checks
Assist with the development of Data Management Plans
Query data inconsistencies in compliance with standard operating procedures, client guidelines and applicable regulatory agency guidelines under the direction of the Lead CDM
Assist with database quality audits as needed
Ensure adequate filing and archiving of relevant data and documentation
Associate degree in a health related discipline required; Bachelors degree preferred,
A minimum of 1 year of experience as a Clinical Data Manager in a CRO, Pharmaceutical, Medical Device and/or Biotechnology setting
Direct experience with FDA regulations for healthcare such as 21 CFR Part 11A a plus along with knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management.
Experience with data management systems such as Oracle.
Basic understanding of database design and database concepts.
Preferable to have experience with understanding SQL
Experience with Electronic Data Capture (EDC) preferred
Proficiency in MS Office applications.
Familiarity with medical terminology
Experience with coding dictionaries (MedDRA, WHO Drug) a plus
An ability to work independently and in a team setting
Excellent organizational, communication and interpersonal skills are required
Attention to detail, ability to prioritize and handle multiple projects.
Quintiles Transnational - 15 months ago
Quintiles Transnational has plenty to CRO about. One of the world's top contract research organizations (CROs), it helps pharmaceutical...