Clinical Data Management - Associate
Location: Pune, Bengaluru, Kolkata, Hyderabad, Mumbai • Level: Mid Level • Openings: 3 • Type: Full-time
Job description
Job Details
Job Title: Clinical Data Management
Job Location: Mumbai, Pune, Hyderabad, Bangalore, Kolkata
Work Model: Hybrid
Candidate
Expectations
Total and Relevant Experience – 1.5
Years to 10 Years
Candidate Location - Anywhere
Skills – Startup, Conduct, Closeout
Candidate Industry (Pharma)
Diversity – No
Education and
Certification
Qualification: Any Life Science Graduate
Specific Remarks:
Distance education not accepted.
Certification: Not Applicable
Detailed Job
Description
·
Manage clinical
trial data from collection through database lock.
·
Review, clean,
validate, and reconcile clinical study data.
·
Develop and
review CRFs/eCRFs, edit checks, data validation specifications, and data
management plans.
·
Perform data
review, query generation, tracking, and resolution.
·
Coordinate with
Clinical Operations, Biostatistics, Medical Coding, Safety, and other study
teams.
·
Perform data
reconciliation across EDC, labs, safety, and other external data sources.
·
Support database
testing, UAT, and database lock activities.
·
Maintain clinical
data management documentation in accordance with SOPs, GCP, and applicable
regulations.
·
Identify data
issues and support process improvements.
Key Skills
Knowledge of clinical trials and the
clinical data management lifecycle.
Experience with EDC systems such as Medidata
Rave, Inform, Veeva is advantageous.
Knowledge of medical coding and data
reconciliation is a plus.
Strong analytical, communication,
documentation, and problem-solving skills.
Mandatory Skills:
Set up - Edit check , UAT, EDC,
Protocol review
Conduct - Query Management
, External Data Reconciliation, Data Validation and Cleaning
Close out: Database Lock
Other Specific
Remarks
Additional
Requirements: Proper documents
for entire career and PF Form 16 Mandatory
Job ID: 2038