07 Sep
|
Caidya
|
Thiruvananthapuram
07 Sep
Caidya
Thiruvananthapuram
Job Title:Clinical Data AssociateJob Location: Trivandrum, Kerala
Job Overview:
The Clinical Data Associate assists the Clinical Data Manager with the process of cleaning and validating data in clinical trials in accordance with Clinipace SOPs, Positive Clinical Practice, ICH Guidelines and sponsor requirements.
Job Duties and Responsibilities:
The specific job duties of a Clinical Data Associate may include but are not limited to:
Assists in reviewing, processing and updating query responses, as needed or assigned
Assists with start-up activities including:
Creation and entry of test data for data entry screen validation
Set up of patient and investigator information
For specified projects assists on some data management activities as detailed below and performs activities in accordance with our SOPs, Positive Clinical Practice, ICH Guidelines and study documentation.
Study status tracking
Data Entry
Review of data listings
Identification of data issues and query generation
Updating of database with query resolutions (on paper studies only)
based on platform need.
Archiving of critical documents on an ongoing basis
Assists with maintaining and updating Data Management Plans and any other relevant Data Management Documentation.
For any legacy paper studies, assists with reviewing and processing Data Clarification Forms, reviewing data listings and quality control reports and updating clinical databases
Participates in assigned study finalization activities including:
Reconciliation
Critical item review
Quality Control
Archiving
Participation in appropriate project team meetings
Manages time in accordance with allocated hours for task
Review and awareness of core study documents
Protocol, Data Management Plan, CRF completion guidelines, DVP, etc. as applicable for the study
Awareness and implementation of the data reconciliation requirements as documented in the associated Data Management documents.
Awareness and support for
📌 Clinical Data Associate Thiruvananthapuram
🏢 Caidya
📍 Thiruvananthapuram