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Clinical Data Analyst I
3 months ago
When our values align, there's no limit to what we can achieve.
Must have 6 months to 1 year of experience in Clinical data management.
Data Validation (cleaning):
Responsible for/start to lead data cleaning and data review activities (Co-Primary CDA/Primary CDA), e.g. query management and manual/SAS listing reviews. Support/start to lead data processing activities from database setup to database lock, e.g. external vendor data reconciliation.Data Management Documents/Plans (Trial Master File):
Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines.Study Start-Up Activities and User Acceptance Testing (UAT):
Start to lead/perform user acceptance testing on clinical database setups. Start to review protocols and EDC Entry Screens if required.Data Tracking and Entry:
Track and review CRFs. Support data entry where required.Project Quality Management & Compliance:
Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines. Support/start to lead functional QC activities on databases and/or patient data, as per business needs.Training:
Maintain training compliance as per Job Roles assigned, including On-the-Job training. Address training needs, as per Development Goal/s identified.Skills:
Evidence of strong problem-solving skills and logical reasoning Commitment to first time quality, including a methodical, analytical and accurate approach to work activities (attention to detail) Time management and prioritization skills in order to meet objectives and timelines Evidence of ability to work collaboratively within a team environment Good interpersonal, oral and written communication skills Learning ability and knowledge sharing approach; swift understanding of technologies and new processes A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing technical environments Evidence of accountability relative to Key Accountabilities in Job Description Written and oral fluency in English
Knowledge and Experience:
Location: Only office Based
Education:
Bachelor’s degree and/or other medical qualifications or relevant industry experience.