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Clinical Data Analyst II (South Africa)

Parexel International Corporation

South Africa - Any Region - Home Based

The CDAII shall independently perform all clinical data cleaning activities on assigned projects, commensurate with experience and/or project role. Further responsibilities shall include acting as Study Team Lead, support on data processing activities and study level documents e.g. Protocol Deviation Specification, Data Validation specification, etc. The CDAII may act as a Data Management Lead where required.QualificationsKnowledge and Experience:

* Experience in clinical research

* Good interpersonal, verbal and written communication skills

* Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG)

* Ability to work in team environment

* Good analytical skills and attention to detail

* Effective time management to meet daily metrics or team objectives, completion of assigned tasks in a timely manner

* Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and Parexel SOP's and study specific procedures

* Good knowledge of EDC systems (e.g. DataLabs, Rave.)

* Good knowledge of electronic source data capture systems (e.g. ClinBase)

* Good knowledge of all DB set- up activities including but not limited to Database Configuration Specifications, Data Validation

* Basic knowledge of SAS

Education:

* Bachelor’s degree and / or other medical qualifications or relevant industry experience

Skills:

* Personal skills that include:

o Good interpersonal, oral and written communication skills

o Excellent learning ability

o Work with integrity

* Business / Operational skills that include:

o Commitment to quality

o Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards

o Sound awareness of relevant regulations, including ICH-GCP, 21CRF11

Job posted: 2021-12-08

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