Clinical Data Management

Zohorecruit; Chennai District; On-site; INR 1,200,000 - 2,500,000; Full time

Job summary

Zohorecruit in Chennai, Tamil Nadu, seeks an experienced Clinical Data Manager to lead data management planning, CRF design, and database setup for complex trials across client projects.

You will act as the clinical data point of contact for internal and external stakeholders, lead CDM tasks, mentor junior staff, perform UAT and migrations, and ensure compliance with GCP and SBP/SDTM CDASH standards.

Qualifications

• Bachelor’s degree in a relevant field or equivalent experience.
• Minimum five years of hands-on clinical data management in clinical trials.
• Experience with database design and EDC/eCRF design.
• Working knowledge of GCP guidelines.
• Advanced proficiency with Microsoft Office; AI knowledge is a plus.

Responsibilities

• Lead data management planning, CRF design, and database setup.
• Act as clinical data point of contact for assigned studies.
• Lead CDM tasks for processing radiological images per SOPs.
• Author study documents (DMP, eCCG, DTA).
• Lead setup, conduct, and lock phases of trials.
• Mentor and train team members.
• Perform UAT, validation & migrations as required.
• Coordinate data linkage between processes and stakeholders.
• Contribute to RBQM and data analytics metrics.
• Ensure compliance with CDASH/SDTM standards.

Skills

Data management

CRF design

Database design

EDC systems

eCRF design

GCP knowledge

UAT

QA/QMS knowledge

Mentoring

RBQM

Education

Bachelor's degree

Tools

MS Office

AI knowledge

EDC tools

Job description

• Lead data management planning, CRF design, and database setup
  
• Act as clinical data point of contact for assigned clinicalstudies for internal and external stakeholders
  
• Lead clinical data management aspects of processingradiological images received for client projects in accordance withstandard operating procedures
  
• Lead CDM Tasks & Process in accordance with SOPs’ &Internal QMS Process.
  
• Author the study documentation of the trial related CDMdocuments (DMP, eCCG, DTA etc…)
  
• Lead the set-up, conduct and Lock phases of the trial
  
• Mentor , Train team members with less experience in gainingknowledge and learning process.
  
• As required understand new EDC Tools and deliver performance insuitable applicable time.
  
• Follow the internal Quality process for delivering milestoneswith quality
  
• Understand the annotations of eCRFs, data linkage between theprocess and stakeholders, coordinate with all stakeholders.
  
• Perform Query management, Offline listings review, externalreconciliation and other DM tasks as and when required.
  
• Contribute to RBQM Process , support data analytics team forgeneration of required standard metrics.
  
• Review, understand and apply the regulatory standards (CDASH,SDTM ).
  
• Perform UAT, Validation & Migrations as required.
  
• Perform other DM Tasks as required,
  

Education and experience

• Bachelor’s degree or equivalent combination of education andrelevant professional experience is required.
  
• Minimum Five years’ hands-on clinical data managementexperience in clinical trials is required.
  
• Experience with database design and implementation,particularly EDC systems and eCRF design, is expected.
  
• Working knowledge of Good Clinical Practice (GCP) guidelines isrequired.
  
• Advanced proficiency with Microsoft Office and preferably someAI knowledge.