The Clinical Data Analyst II (CDA II) performs all clinical data validation activities on assigned projects, commensurate with experience and/or project role with minimal guidance and supervision from Line Manager and/or Subject Matter Expert. Further responsibilities shall include support on data validation activities, Data Management documents and data cleaning matrices e.g. Data Validation Specification, CRF Completion Guidelines, Protocol Deviation Specification, Mock Shells for Off-line listing etc.
All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
CDA II may act as a mentor for ACDA or other CDA peers and also as a process lead on a specific data validation activity.Qualifications
· 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
· Ability to coordinate & prioritize tasks for the team when in the Primary CDA role.
· 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
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