Data Analytics Bootcamp Coach — Remote, Uk Hours

Io Sphere; Cape Town; Remote; ZAR 480,000 - 820,000; Full time

Job summary

Io Sphere is seeking a Clinical Data Analyst II to perform comprehensive data validation on assigned clinical projects, ensuring accuracy and regulatory compliance. You will support data management documents, assist in data cleaning matrices and mentor peers in data validation processes.

The role requires experience in clinical research data management, familiarity with MedDRA coding, and knowledge of systems like InForm and Rave.

Qualifications

• Experience in clinical research with data management or lab experience, minimum 2 years.
• Knowledge of medical terminology and coding dictionaries (e.g. MedDRA).
• Familiar with data management processes in study start-up, conduct and close-out.
• Understanding of Clinical Data Management Systems (InForm, Rave, Veeva).

Responsibilities

• Perform clinical data validation activities on assigned projects with minimal supervision.
• Support data management documents and data cleaning matrices.
• Mentor ACDA or CDA peers and act as process lead on data validation.
• Ensure work complies with ICH-GCP and SOPs.

Skills

Data management

Clinical research

SAS

CDISC

Communication skills

Education

Bachelor's degree in related field

Tools

InForm

Rave

Veeva

DataLabs

ClinBase

Job description

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The Clinical Data Analyst 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 with corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.
The 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.
_What you'll bring to the role;_
Knowledge and Experience :
+ Experience in clinical research industry with sound Data Management / Lab experience (minimum 2 years)
+ 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
+ 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 Parexel SOP's 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
+ Basic knowledge of SAS (programmed listings)
+ Basic knowledge of Data standards (CDISC)
+ Strong technical aptitude with awareness/potential prior experience in Microsoft Office Products (basic computer skills).
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
+ Evidence of accountability
+ Written and oral fluency in English
Education:
+ Bachelor's degree and / or other related medical qualification
_Your Core Responsibilities_ _: