What does a Clinical Data Analyst do?

Explore the responsibilities, collaboration, and growth opportunities of a Clinical Data Analyst I in the Clinical Research Industry

Q: What are the job responsibilities of a Clinical Data Analyst I?

A:  A Clinical Data Analyst I at Parexel has several key responsibilities:

• Data Validation and Cleaning: Perform and begin to lead data cleaning and review activities, including query management and manual/SAS listing reviews.
• Data Processing: Support data processing activities from database setup to database lock, including external vendor data reconciliation.
• Documentation: Assist in creating and maintaining Data Management documents and plans, ensuring compliance with Standard Operating Procedures and ICH-GCP Guidelines.
• User Acceptance Testing (UAT): Participate in and start to lead UAT on clinical database setups, and review protocols and EDC Entry Screens.
• Data Tracking and Entry: Track and review Case Report Forms (CRFs) and support data entry when required.
• Quality Management: Ensure compliance with SOPs and ICH-GCP Guidelines, and support functional QC activities on databases and patient data.
• Continuous Learning: Maintain training compliance and address personal development goals.

It's important to note that while a bachelor's degree is the standard requirement, Parexel values a combination of education and practical experience. Candidates with a strong background in clinical research or data management may be considered even if their degree is in a different field.

Q: What career progression is typical for a Clinical Data Analyst I?

A: The career progression for a Clinical Data Analyst I typically follows this path:

• Clinical Data Analyst I: Entry-level position focusing on basic data management and cleaning tasks.
• Clinical Data Analyst II: Increased responsibilities in data processing and documentation.
• Senior Clinical Data Analyst: Lead more complex projects and mentor junior team members.
• Data Management Lead: Oversee multiple studies and coordinate with various stakeholders.
• Clinical Data Manager: Manage a team of analysts and oversee data management strategies for multiple studies.
• Associate Director/Director of Data Management: Develop and implement data management strategies at an organizational level.

As CDAs gain experience, they may also specialize in areas such as data standards, EDC systems, or data analytics.

Q: Which roles do I collaborate with as a Clinical Data Analyst I? 

A: As a Clinical Data Analyst I, you'll collaborate with various roles within the clinical research team:

• Senior Clinical Data Analysts and Managers: For guidance, mentoring, and task delegation.
• Clinical Research Associates (CRAs): Coordinate on data quality and query resolution.
• Biostatisticians: Ensure data is clean and ready for statistical analysis.
• Medical Writers: Provide clean data for clinical study reports and publications.
• Project Managers: Align on timelines and project deliverables.
• Data Programmers: Work together on database setup and data validation checks.
• Clinical Scientists: Clarify medical queries and protocol-related issues.
• Quality Assurance Specialists: Ensure compliance with regulatory standards and SOPs.
• External Vendors: Collaborate on data reconciliation and integration.

Q: How does a Clinical Data Analyst I in clinical research differ from other industries?

A: A Clinical Data Analyst I in clinical research differs from data roles in other industries in several ways:

• Regulatory Compliance: CDAs must adhere to strict regulations like ICH-GCP, FDA, and EMA guidelines.
• Medical Knowledge: They need a basic understanding of medical terminology and coding dictionaries (e.g., MedDRA, WHODRUG).
• Specialized Systems: CDAs work with Clinical Data Management Systems (CDMS) specific to the industry.
• Data Sensitivity: They handle sensitive patient data, requiring a high level of confidentiality and ethics.
• Impact on Patient Safety: Their work directly affects patient safety and the development of new treatments.
• Cross-functional Collaboration: CDAs work closely with various roles unique to clinical research.
• Timeline Criticality: Strict timelines in clinical trials make efficiency and accuracy crucial.

Q: Will I have to travel as a Clinical Data Analyst I? 

A: Generally, Clinical Data Analyst I positions have limited travel requirements. Most of their work can be done remotely or from an office location. However, some travel may be necessary for:

• Team meetings or training sessions
• Investigator meetings at the start of a clinical trial
• On-site visits to clinical trial locations for data review or troubleshooting (less common for entry-level positions)
• Conferences or industry events for professional development

The amount of travel can vary depending on the specific role, project requirements, and company policies. At Parexel, we strive to maintain a good work-life balance while meeting the needs of our clients and studies.

Q: Are there remote job opportunities as a Clinical Data Analyst I? 

Yes, there are often remote job opportunities available for Clinical Data Analyst I positions at Parexel and in the broader clinical research industry. The nature of data management work, which primarily involves computer-based tasks and virtual collaboration, makes it well-suited for remote work arrangements. However, the availability of remote positions may depend on factors such as:

• Project requirements
• Client preferences
• Company policies
• Regulatory considerations

Parexel recognizes the benefits of flexible work arrangements and offers remote or hybrid options for many roles, including Clinical Data Analyst I positions, where possible. This approach allows us to attract top talent globally while providing our employees with a better work-life balance.

• Individual experience level