Clinical Data Coordinator I
Location: Mumbai
Category: Clinical
Job ID: 254474
Job Overview
Support the Lead Data Manager (LDM) in reviewing, maintaining, and updating external vendor data received from central vendors or local laboratories. Ensure adherence to departmental SOPs, guidelines, and global standards to maintain data integrity and consistency across projects.
Summary of Responsibilities
(Not exhaustive; may include other duties as assigned)
Ensure electronic vendor data:
Contains all protocol-specified parameters
Is in the correct format
Accurately populates specified fields and patient records
Support LDM in developing Data Transfer Agreements and Data Transfer Specifications for vendor data transfers.
Review data discrepancies from study-specific edit checks for external data and manage query resolution.
Assist LDM with validation reviews of electronically transmitted data for patient samples prior to loading.
Review External Data edit checks, status reports, and listings.
Interact with clinical staff (CTM/CRA) to obtain local laboratory normal ranges for sites, research discrepancies, and maintain documentation.
Enter and perform QC on local laboratory normal ranges; verify attachment to patient results in the database.
Support LDM in vendor and client communications regarding data transfers, data point issues, and validation concerns (with oversight from EDS 2 or above).
Qualifications (Minimum Required)
University/college degree in Life Sciences, Health Sciences, Information Technology, or related subjects.
Certification in allied health professions from an accredited institution acceptable.
Fortrea may consider relevant and equivalent experience in lieu of formal education.
Fluent in English (written and verbal).
Experience (Minimum Required)
3 years’ prior experience in pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries, or an equivalent combination of education and experience.
Basic understanding of medical terminology (preferred).
Strong organizational, planning, and critical-thinking skills.
Effective, inclusive communication skills (written and verbal) for sponsor and colleague interaction.
Ability to manage multiple tasks under demanding conditions.
Proficiency with Microsoft Office Suite.
Strong technical aptitude.
Ability to maintain confidentiality of sensitive data.
Understanding of ICH-GCP principles.
Physical Demands / Work Environment
General or remote office setting.
Prolonged sitting and computer use.
Frequent interruptions and shifting priorities.
Ability to manage multiple priorities effectively.
Willingness to work flexible shifts as per business needs.
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Queensland |Remote Australia :
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Nedlands |Capital of Netherland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Sofia |Canada :
Canada |Ontario :
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Ho Chi Minh City |