Job Description

A Clinical Data Associate (CDA) is responsible for ensuring the accuracy, completeness, and integrity of clinical trial data by performing data entry, validation, and query resolution. This role involves collaborating with clinical data management and other teams to support study setup and closeout, tracking data flow, and ensuring compliance with protocols and regulations like ICH-GCP. Key responsibilities include performing quality control checks, maintaining study documentation, and preparing data for analysis. Core responsibilities

Data management:

Enter, validate, and reconcile data from case report forms (CRFs) into electronic data capture (EDC) systems.
Key skills and qualifications

Education:

A bachelor's degree in life sciences, computer science, or a related field is often required.

Experience:

Previous experience in clinical data management or a similar role is preferred, with some positions requiring 1-3 years of experience.

Technical skills:

Proficiency in EDC systems (like Medidata Rave or Veeva Vault) and familiarity with data analysis software (such as SAS) are beneficial.

Attention to detail:

A high degree of accuracy and attention to detail is critical.

Communication:

Strong verbal and written communication skills are necessary for interacting with different teams and stakeholders.

Problem-solving:

The ability to work both independently and as part of a team to solve problems is essential.

Knowledge:

Knowledge of clinical trial terminology, ICH-GCP guidelines, and regulatory requirements is important.

Quality control:

Perform quality control checks to identify and resolve data discrepancies by raising and resolving queries.

Compliance:

Ensure all data management activities comply with the clinical study protocol, Good Clinical Practice (GCP), and other regulatory guidelines.

Documentation:

Maintain accurate and up-to-date study documentation and electronic databases.

Collaboration:

Work with clinical data management, study sites, and other teams to support study activities. Tamil candidates only
Job Type: Full-time

Pay: ?11,673.19 - ?25,332.15 per month

Benefits:

Food provided
Work Location: In person