A Clinical Data Analyst is a professional who plays a vital role in the healthcare industry. They are responsible for collecting, organizing, and analyzing clinical data to derive valuable insights that contribute to medical research, patient care, and overall healthcare improvements. In this blog post, we will describe the primary responsibilities and the most in-demand hard and soft skills for Clinical Data Analysts.

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Main Responsibilities of a Clinical Data Analyst

The following list describes the typical responsibilities of a Clinical Data Analyst:

Adhere to

Adhere to all aspects of SDC's quality system.

Analyze

• Analyze data, identifies trends.

• Analyze data using statistical methods and software tools.

Apply

• Apply and promotes best practices and established standards.

• Apply best practices and established standards.

Assist in

• Assist Business Analysts with writing technological standards and design documentation.

• Assist in creation and maintenance of material specifications managed by the product research group.

• Assist in the development and maintenance of data dictionaries and codebooks.

• Assist in the development of data management plans and strategies.

Assume

• Assume any tasks outlined in Clinical Data Analyst job description, as needed.

• Assume Clinical Data Manager responsibilities for small studies.

Attend

Attend routine project team calls to discuss findings as appropriate.

Audit

Audit database contents for accuracy and validity.

Build

Build features and tools that give the analytics team the resources they need to solve problems.

Collaborate with

• Collaborate with healthcare professionals and researchers to define data requirements.

• Collaborate with IT professionals to maintain and optimize data systems and infrastructure.

• Collaborate with other clinical data analysts and actuaries to propose solutions.

• Collaborate with stakeholders to define research objectives and data collection methods.

Collect

• Collect, analyze, prepare and present health and administrative data.

• Collect data from various sources and ensure its accuracy and integrity.

Communicate

• Communicate and collaborates with all levels of employees.

• Communicate and collaborates with all levels of employees, customers, contractors, and vendors.

• Communicate findings and recommendations to diverse audiences, including non-technical stakeholders.

• Communicate well with peers, study teams and management as appropriate to support studies and goals.

Complete

Complete User Access Request Forms.

Conduct

• Conduct data audits and resolve any inconsistencies or discrepancies.

• Conduct exploratory data analysis to identify potential research areas.

• Conduct risk assessment and management for clinical data projects.

• Conduct statistical analysis of data to identify patterns.

• Conduct statistical analysis to identify correlations and associations within datasets.

Create

Create reports and presentations summarizing data analysis findings.

Design

Design and implement conversion or raw data from multiple sources into analytic data model.

Develop

• Develop and implement data validation checks and quality control measures.

• Develop and maintain databases to store clinical data securely.

• Develop data collection protocols and procedures.

• Develop predictive models and algorithms to forecast patient outcomes.

Edit

Edit Check specifications development and maintenance.

Ensure

• Ensure alignment across the data sciences team members.

• Ensure clinical data integrity and quality prior to analysis.

• Ensure compliance with regulatory requirements and standards.

• Ensure consistency across deliverables within and across therapeutic areas and business partners.

• Ensure data sets and reports are built to specifications.

• Ensure that quality of services meets internal and external customer requirements.

Establish

Establish standards to be used in the design and development of key system interfaces.

Exercise

Exercise judgement within defined standards and guidelines.

Facilitate

Facilitate and participates in peer review meetings for each of the deliverables.

Follow

Follow standard practices and procedures and works on projects of minimally complex nature.

Format

Format output of data analysis for internal / external customer readiness.

Generate

Generate, send and track receipt of Training Forms for new database users.

Handle

Handle the reconciliation and analysis of internal and external data related issues.

Identify

• Identify opportunities for automating data quality checks using advanced statistical techniques.

• Identify opportunities for process improvement and data optimization.

• Identify opportunities regarding to data processing, visual display, and analysis.

• Identify trends and patterns in data to support decision-making and research.

Influence

Influence key stakeholders across functions and across hierarchies.

Interact with

• Interact with clients to clarify needs and in reviewing results.

• Interact with customers to clarify needs and in reviewing results.

Lead

• Lead a matrixed and cross-functional data review team in support of clinical trial life cycle.

• Lead efforts to improve Data Management processes, as needed / assigned.

Maintain

• Maintain effective and timely communication with all team members and documents all communication.

• Maintain knowledge of group dynamics, strong analytical, organizational and communication skills.

• Maintain quality control of the data, project deliverables and closeouts.

• Maintain working knowledge of regulatory issues, which impact the health care delivery system.

Manage

Manage processes to improve the mapping and normalization of content within OM1's database.

Mentor

Mentor and train Clinical Data Analysts in query management and other CDA activities.

Monitor

• Monitor and ensure compliance with data protection and privacy regulations.

• Monitor and validate fidelity of data pipelines and models.

• Monitor performance and reports status within area of responsibility.

Obtain

Obtain proper approvals on each of the deliverables.

Oversee

Oversee the delivery of data analysis and review deliverables.

Own

Own and build ETLs to support our ever expanding dimensional models.

Participate in

• Participate and / or lead internal and external team meetings, as necessary.

• Participate in and take minutes for internal and external team meetings, as necessary.

• Participate in interdisciplinary meetings to present data findings and insights.

• Participate in internal and external team meetings, as necessary.

• Participate in Post Market Surveillance reporting as appropriate.

• Participate in the design and implementation of clinical trials and studies.

Perform

• Perform analysis tasks in support of clinical trial data integrity.

• Perform data entry and query management including data listing review, query creation and resolution.

• Perform data entry, query management including review, creation and resolution.

• Perform data mapping and integration tasks to ensure interoperability.

• Perform data mining and data visualization to facilitate understanding and interpretation.

• Perform or coordinate all data management activities for assigned studies, as appropriate.

• Perform other duties as assigned.

• Perform other related duties and responsibilities, on occasion, as assigned.

• Perform remote / phone visits, as required per the CMP and contracted services.

• Perform tasks which regularly require good correctable vision and hand / eye coordination.

Plan

Plan, conduct, and direct the analysis of business problems.

Prepare

• Prepare data tables for clinical reports.

• Prepare data tables for reports.

Provide

• Provide guidance and support to junior data analysts or research teams.

• Provide overall quality assurance oversight from requirements through post-release.

• Provide quality assurance on all assigned reporting and data extracts.

Represent

Represent the Data Management group at study team meetings and cross-functional task forces.

Stay updated with

Stay updated with industry standards and best practices in clinical data management.

Study

Study Database setup testing and Edit Check programming testing.

Support

Support data-driven decision-making by providing accurate and timely information.

Train

Train and mentors other Clinical Data Associates (CDAs) and Clinical Data Coordinators (CDCs).

Use

Use change management process and tools.

Utilize

Utilize engineering principles in diagnosing and correction issues.

Validate

• Validate and clean data to ensure quality and reliability.

• Validate data and perform analysis as needed.

Work with

• Work on multiple projects simultaneously in a fast-paced, dynamic environment.

• Work well in closely-knit team environments of various technical backgrounds and skillsets.

• Work with electronic health records (EHR) systems and other healthcare IT tools.

• Work with operations to make sure our warehousing data is secure and compliant.

• Work with other clinical data analysts and actuaries.

• Work with our analytics team to ensure our data governance is robust.

• Work with the data warehouse teams to ensure data sets and reports are built to specifications.

Most In-demand Hard Skills

The following list describes the most required technical skills of a Clinical Data Analyst:

1. Proficiency in statistical analysis software (e.g., SAS, R, Python, SPSS).

2. Strong knowledge of data management and database systems (e.g., SQL, Oracle, MongoDB).

3. Familiarity with clinical research processes and methodologies.

4. Expertise in data visualization tools (e.g., Tableau, Power BI, matplotlib).

5. Experience with electronic data capture (EDC) systems.

6. Understanding of data warehousing and data integration techniques.

7. Knowledge of healthcare terminologies and coding systems (e.g., SNOMED CT, ICD-10).

8. Ability to perform data mining and machine learning techniques.

9. Proficiency in data modeling and data architecture.

10. Strong understanding of biostatistics and epidemiology principles.

11. Knowledge of clinical trial regulations and guidelines (e.g., FDA, ICH-GCP).

12. Experience with clinical data standards (e.g., CDISC).

13. Familiarity with data anonymization and de-identification techniques.

14. Understanding of data security and privacy regulations (e.g., HIPAA, GDPR).

15. Proficiency in data manipulation and transformation techniques.

16. Knowledge of data validation and quality assurance processes.

17. Ability to work with large datasets and perform efficient data manipulation.

18. Experience with data analysis and visualization software (e.g., Excel, MATLAB, Stata).

19. Proficient in data cleaning and data preprocessing techniques.

20. Familiarity with data governance and data stewardship principles.

Most In-demand Soft Skills

The following list describes the most required soft skills of a Clinical Data Analyst:

1. Strong analytical and problem-solving skills.

2. Excellent attention to detail and accuracy.

3. Effective communication skills, both verbal and written.

4. Ability to work collaboratively in interdisciplinary teams.

5. Strong organizational and time management skills.

6. Adaptability and flexibility to handle changing priorities and deadlines.

7. Critical thinking and logical reasoning abilities.

8. Ability to work independently with minimal supervision.

9. Strong ethical standards and respect for data privacy.

10. Continuous learning mindset to stay updated with emerging trends and technologies.

Conclusion

The role of a Clinical Data Analyst is crucial in the healthcare industry, as they are responsible for extracting insights from complex clinical data. By understanding their main responsibilities and acquiring the necessary hard and soft skills, these professionals can play a pivotal role in improving patient care, enhancing medical research, and driving evidence-based decision-making in the healthcare sector.