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Coordinator II, Clinical Data

4 months ago

Delhi, Delhi, India Abbott Laboratories Full time
MAIN PURPOSE OF ROLE

Summary of the main goal of this position.

Working under general supervision, this role is accountable for maintaining the accuracy of clinical data within the database. Responsibilities include entering, reviewing, verifying, adjusting, and organizing incoming clinical data. Identifying potential issues that may impact data quality and addressing them appropriately. Providing administrative support for clinical studies and proposing solutions to enhance efficiency and quality in the data management process. Ensuring missing data is clarified with external clients. Employing basic judgment in planning and organizing tasks. Ensuring service quality meets both internal and external expectations. This role will primarily handle assigned studies with basic knowledge of all studies managed by the clinical data group.

MAIN RESPONSIBILITIES
  • Primary Responsibility involves working with Clinical Data, specifically reconciling required images captured at the site level on Case Report forms with images uploaded to a third-party image repository by the clinical site. This includes issuing queries for missing images, reviewing query responses, and verifying image uploads. Additionally, it entails reconciling CRF data and Third-Party Image platform with the core lab for analysis. Other duties include reconciling key identification fields of the CRF, Third-Party Image platform, and core lab.
  • Accurately processing incoming clinical data forms according to departmental procedures. This includes entering data forms into a database, reviewing and verifying already entered forms, correcting errors, and organizing clinical documentation.
  • Supporting discrepancy management by preparing data clarification forms based on the review of incoming clinical data for missing or incorrect information.
  • Identifying issues and discussing challenges related to clinical data coordination.
  • Maintaining data integrity in the clinical database through thorough review of clinical data forms and identification of discrepancies. Also responsible for ensuring the integrity of meta-data study information and providing support to the clinical evaluation department for on-site monitoring visits. Resolving problems and preventing recurrence of issues.
QUALIFICATIONSEducation

Education Level

Major/Field of Study

Or

High School Diploma / GED

Or other specialized training/equivalent related experience.

An equivalent combination of education and work experience

Experience/Background

Minimum 2 years of experience as a Clinical Data Coordinator or in a similar clinical research environment. Familiarity with data management procedures, organizational skills, attention to detail, and ability to handle multiple projects simultaneously. Strong interpersonal skills, ability to resolve problems, handle unexpected events, and maintain effective communication. Experience with FDA, GMP, and GCP regulations. Ability to work in a diverse business environment, collaborate within a team, and independently in a fast-paced setting. Excellent verbal and written communication skills with the ability to communicate effectively at all levels. Strong organizational, follow-up, and attention to detail abilities.

Minimal travel may be required. Regular and predictable attendance is essential.