Job Title
Clinical Data Management – External Vendor Data Support (LDM Support Role)
Experience: ~3 Years (or equivalent)
Work Environment: Office / Remote
Shift Requirement: Flexible shifts may be required
Job Overview
This role supports Local Data Management (LDM) activities related to external vendor and laboratory data management.
You will ensure:
Data integrity
Consistency across clinical studies
Compliance with SOPs, global standards, and regulatory guidelines
The focus is on managing, reviewing, and validating external clinical trial data (e.g., lab vendors, local laboratories).
Key Responsibilities
1. External Vendor Data Management
Review and maintain external vendor and local laboratory data
Ensure:
Protocol-specified parameters are correctly included
Data format is accurate
Data maps correctly to patient records and database fields
2. Data Transfer Support
Support development of:
Data Transfer Agreements (DTA)
Data Transfer Specifications (DTS)
Assist in managing vendor data transfers and validation processes
3. Data Review & Query Management
Review discrepancies from study-specific edit checks
Manage and resolve data queries
Ensure timely correction of data issues in collaboration with stakeholders
4. Data Validation & Quality Control
Support validation of electronically transferred data for sample patients
Review:
External data status reports
External data listings
Edit checks
5. Laboratory Data Management
Collaborate with Clinical Operations teams (CRA/CTM)
Obtain local laboratory normal ranges for study sites
Resolve discrepancies in lab reference ranges
Perform QC on lab normal range data
Ensure correct mapping of lab ranges to patient records
6. Vendor & Stakeholder Communication
Communicate with vendors and internal teams regarding:
Data transfer issues
Data discrepancies
Validation problems
Provide initial support under supervision (EDS level guidance)
7. Documentation & Compliance
Maintain proper documentation of all data-related activities
Ensure adherence to:
ICH-GCP guidelines
SOPs and global data standards
Maintain confidentiality of clinical data
8. Additional Responsibilities
Perform any other tasks as assigned
Support continuous improvement of data processes
Required Qualifications
University/college degree in:
Life Sciences
Health Sciences
Information Technology
Related fields
OR
Equivalent certification in allied health professions
Fluent in English (written & verbal)
Experience Required
Minimum 3 years in:
Pharmaceutical industry
Biotechnology
Medical device/diagnostics
Clinical trials
OR equivalent combination of education and experience
Key Skills Required
Strong understanding of medical terminology (preferred)
Good organizational and planning skills
Strong analytical and critical thinking ability
Excellent communication skills (written & verbal)
Ability to multitask under pressure
Strong technical aptitude
Proficiency in Microsoft Office tools
Ability to maintain confidentiality of sensitive data
Understanding of ICH-GCP principles
Work Environment
Office or remote setup
Frequent task interruptions
Requires priority switching and multitasking
Structured but fast-paced environment
Flexible shift work may be required
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Remote, India | Siliguri |Illinois :
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Germany | GErmany |Lower Saxony :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Dunboyne |Dún Laoghaire :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
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Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
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Queensland |Melbourne :
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Canada |Quebec :
Montreal |Brussels :
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Greece |North Island :
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Madrid |Cebu Province :
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Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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