Clinical Data Risk Analyst (Sponsor Dedicated)

ICON; Johannesburg; Hybrid; ZAR 300,000 - 400,000; Full time

Job summary

A leading healthcare intelligence organization is seeking a Clinical Data Risk Analyst. This role involves responsibility for the setup and implementation of Central Monitoring in clinical studies. Candidates should have strong knowledge in Clinical Research, Risk-Based Quality Management, and proficiency in SAS and Python. The position offers a competitive salary and various benefits supporting work-life balance.

Benefits

Various annual leave entitlements

Health insurance options

Retirement planning

Global Employee Assistance Program

Life assurance

Flexible country-specific benefits

Qualifications

• Strong knowledge of Clinical Research, Risk-Based Quality Management, and Central Monitoring.
• Experience with Cluepoints and its smart engine.
• Proficiency in SAS and Python, including program development and debugging.

Responsibilities

• Identify data sources and propose data preparation approaches.
• Prepare datasets based on specifications and set up Cluepoints reports.
• Conduct additional analyses with B&P/TO teams to understand findings.

Skills

Clinical Research

Risk-Based Quality Management

Central Monitoring

SAS

Python

Tools

Cluepoints

Job description

Clinical Data Risk Analyst - Bulgaria, Sofia Hybrid: Office/Remote

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Clinical Data Risk Analyst - Sponsor Dedicated

Remote

The Role:

We are looking for a Clinical Data Risk Analyst/Data Scientist to join the Clinical Risk Management team at ICON. Candidates should have strong knowledge of Clinical Research, Risk-Based Quality Management, and Central Monitoring in the Pharma or CRO industry.

The Clinical Data Risk Analyst, as the functional lead of Clinical Risk Management, is responsible for setup and implementation of Central Monitoring on a portfolio of clinical studies.

What you will be doing

The responsibilities of the Data Scientist include, but are not limited to:

• Identify data sources and propose data preparation approaches, e.g., using raw data sets as input
• Select and possibly combine key variables
• Prepare datasets based on specifications
• Set up and refresh Cluepoints reports (KRI, DQA) regularly according to study specifics
• Conduct additional analyses with B&P/TO teams to understand findings if appropriate
• Interpret findings for RBM central monitors to understand signals
• Prepare reports summarizing results, data findings, and signals
• Support the definition of actions to adapt RBM strategies based on signals
• Collaborate closely with RBM Central Monitors
• Follow RBM processes for global and local teams
• Mentor new RBM Data Scientists

Experience & Skills

Experience with Cluepoints is highly valued, including understanding of CluePoint's smart engine, setup of KRI & DQA dashboards, and report refresh processes.

Proficiency in SAS and Python is required, including developing programs, updating parameters, debugging, and executing code.

Experience in writing KRI specifications and translating natural language to programming language is also important.

What ICON can offer you

We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, we offer benefits focused on well-being and work-life balance, such as:

• Various annual leave entitlements
• Health insurance options
• Retirement planning
• Global Employee Assistance Program (TELUS Health)
• Life assurance
• Flexible country-specific benefits (childcare vouchers, gym discounts, travel passes, health assessments, etc.)

ICON is an equal opportunity employer committed to an inclusive workplace. If you require reasonable accommodations during the application process due to a medical condition or disability, please let us know.

We encourage all qualified candidates to apply, even if they do not meet every requirement. For current ICON employees, please apply here.