Technical Officer – CDM EP
Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, Gujarat
Req ID: 1589
Employment Type: Full-Time
Department: Clinical Data Management (CDM) – Early Phase
CTC Offered: ₹3.5 – ₹7 LPA
About the Role
Lambda Therapeutic Research is hiring a Technical Officer – CDM EP to support Clinical Data Management activities for Early Phase BA/BE and PK studies. The role involves designing eSource CRFs, developing edit checks, performing testing activities, and ensuring high-quality electronic data capture for in-house clinical studies.
Key Responsibilities
eSource CRF Development
Create and maintain eSource CRFs for in-house BA/BE and PK studies.
Design study-specific electronic data capture forms.
Ensure CRFs align with protocol and study requirements.
Support updates and modifications based on study needs.
Edit Check Development
Develop and configure edit checks for clinical databases.
Validate data consistency, completeness, and accuracy.
Identify and resolve data discrepancies through automated checks.
Support query generation and data validation activities.
Testing & Validation
Perform User Acceptance Testing (UAT) of eCRFs and edit checks.
Execute testing scenarios and document findings.
Ensure database functionality before study deployment.
Support system validation and quality assurance activities.
Clinical Data Management Support
Collaborate with Clinical Data Management and study teams.
Support database setup and maintenance activities.
Ensure compliance with study protocols and SOPs.
Contribute to data quality and database integrity initiatives.
Key Deliverables
eSource CRFs for BA/BE and PK Studies.
Edit Check Specifications.
Database Testing Documentation.
UAT Reports.
Clinical Data Validation Outputs.
Required Qualifications
Education:
B.Pharm
B.Sc. (Life Sciences)
Required Skills
Clinical Data Management (CDM)
eCRF Design
eSource CRF Development
Edit Check Programming
Database Testing
UAT Testing
Clinical Research
BA/BE Studies
Pharmacokinetic (PK) Studies
Data Validation
Query Management
Clinical Databases
SOP Compliance
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