Clinical Data
Manager II Clinipace graduate/postgraduate with a life science qualification
Job Overview:
The Clinical Data Manager II participates in the clinical data
management activities for a project within a data management project team;
including processing of case report form (CRF) and electronic data in
accordance with Clinipace SOPs, Good Clinical Practice, ICH Guidelines and
sponsor requirements.
Job
Duties and Responsibilities:
· For specified projects performs
start-up activities including:
· Developing data management guidelines
and study documentation
· Review of CRF design against protocol
· Review of database setup
· For specified projects performs some
data management activities as detailed below and performs activities in
accordance with our SOPs, Good Clinical Practice, ICH Guidelines and study
documentation.
· Study status tracking
· Data Entry
· Review of data listings
· Identification of data issues and
query generation
· Updating of database with query
resolutions (paper studies only)
· Archiving of critical documents on an
ongoing basis
· Participate in User Acceptance
Testing for assigned projects
· For specified projects performs study
finalization activities including:
· Database close-out
· Critical item review
· Quality Control
· Archiving
Job
Requirements:
· Education
· College graduate/postgraduate with a
life science qualification preferred.
· Experience
· Minimum of 3.6 years of experience
and/or demonstrated aptitude for data management work.
· Experience working in pharmaceutical
and/or Contract Research Organization (CRO) industry
· Working knowledge of EDC studies
· Skills/Competencies
· Good organizational skills
· Strong written and verbal
communication skills
· Exceptional attention to detail
· Knowledge of clinical research
including regulatory requirements GCP/ICH
· Strong computer skills, including
Microsoft Office and clinical data management systems
· Good problem-solving skills
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