Parexel are currently recruiting for a Clinical Data Analyst II in South Africa.
In this role, the Clinical Data Analyst II (CDA II) performs all clinical data validation activities on assigned projects, 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.
As a CDA II, you may also act as a mentor for Associate CDA or other CDA peers and also as a process lead on a specific data validation activity.

SKILLS:

• 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.
• Written and oral fluency in English.

KNOWLEDGE AND EXPERIENCE:

• Strong technical aptitude with prior experience in Microsoft Office Products.
• Good understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock).
• Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements and study specific procedures.
• Good knowledge of Clinical Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs, ClinBase).
• Good understanding of Clinical Study Team roles within Data Management.
• Experience in clinical research industry.
• Good knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG).
• Good knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out.
• Good knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation.
• Basic knowledge of SAS (programmed listings).
• Basic knowledge of Data standards (CDISC).

EDUCATION:

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

WHAT WE ARE LOOKING FOR IN THIS ROLE

For every role, we look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart.

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