Clinical Data Analyst

The Clinical Data Analyst specializing in data entry and analysis plays a pivotal role in ensuring accurate and timely data management for clinical trials. This role involves proficiently entering, cleaning, and analyzing data collected during clinical trials while adhering to regulatory guidelines and study protocols.

Responsibilities:

Data Entry: Accurately enter clinical trial data into Sponsor Operations systems or other designated databases in a timely manner, Planisware experience is a plus.

Data Cleaning: Perform data validation and cleaning procedures to ensure accuracy, completeness, and consistency of data.

Quality Control: Conduct quality control checks on entered data to identify and resolve discrepancies or errors.

Data Analysis: Assist in the analysis of clinical trial data, including generating reports, summaries, and graphical representations as required.

Database Management: Maintain organized and up-to-date study databases, including archiving and backing up data as per regulatory requirements.

Regulatory Compliance: Ensure compliance with regulatory guidelines, Good Clinical Practice (GCP) standards, and study protocols related to data management activities.

Collaboration: Collaborate with other study team members, including investigators, clinical research coordinators, and statisticians, to facilitate data management and analysis processes.

Documentation: Maintain accurate and complete documentation of data entry and analysis procedures, including data entry logs, validation checks, and audit trails.

Training and Support: Provide training and support to study staff on data entry procedures, EDC systems, and data analysis tools as needed.

Qualifications:

Bachelor's degree in a relevant field such as statistics, biostatistics, data science, life sciences, or a related discipline. Previous experience in clinical research or data management preferred. Proficiency in data entry and analysis using statistical software (e.g., SAS, SPSS, R) and Microsoft Excel. Strong attention to detail and accuracy in data entry and analysis. Familiarity with regulatory requirements and guidelines for clinical trials (e.g., FDA regulations, ICH GCP guidelines). Excellent organizational and time management skills, with the ability to prioritize tasks effectively. Strong interpersonal and communication skills, with the ability to work collaboratively in a team environment. Ability to maintain confidentiality and handle sensitive information appropriately. Planisware and Power BI experience is a strong plus

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com