TMF Document Coordinator I

Innovaderm Research Inc.

. Maintain the Sponsor’s Trial Master File (TMF) throughout the duration of a clinical trial .

Posted 9/17/2026full-timeRemote • IndiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in maintaining and reviewing Trial Master Files (TMF) in compliance with good clinical practices and regulatory guidelines, while ensuring accuracy and quality in clinical research documentation. Proficient in generating metrics and reports to support project leads and collaborating effectively with project teams.

Highest-signal resume keywords

Trial Master File ManagementClinical Research ExperienceGood Clinical Practices KnowledgeFDA Regulations KnowledgeMicrosoft Word and Excel Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Trial Master File MaintenanceQuality Control WorkflowsRecord ClassificationMetadata AssignmentQuality Issue IdentificationTMF Metrics GenerationDocument ReviewClinical Trial DocumentationRegulatory ComplianceData Accuracy

Soft Skills

Organizational SkillsAttention to DetailAdaptabilityMultitasking AbilityCollaboration

Industry Keywords

BiotechnologyPharmaceuticalCRO IndustryHealth Canada RegulationsFDA GuidelinesClinical Trial Management

About the role

Key responsibilities & impact

Maintain the Sponsor’s Trial Master File (TMF) throughout the duration of a clinical trial
Review and process TMF records through quality control workflows
Review TMF records for completeness, accuracy, and quality prior to approval
Classify records and assign appropriate metadata based on record type
Identify quality issues and issue pre-approval queries
Coordinate with submitters to ensure timely resolution of queries
Participate in TMF quality reviews and address assigned findings
Maintain study milestones and expected document lists
Support the TMF Project Lead in generating monthly TMF metrics and related reports
Attend internal TMF Focus meetings and provide updates on TMF status, issues, and outstanding queries
Collaborate with project team members to resolve issues impacting TMF records

Requirements

What you’ll need

College degree
Experience in clinical research within the biotechnology, pharmaceutical, or CRO industry
Intermediate proficiency in English
Computer skills and proficiency in Microsoft Word and Excel
Good organizational skills with the ability to manage multiple assignments
High attention to detail and accuracy
Ability to meet established timelines, expectations, and objectives
Adaptable and comfortable working in a multitasking environment
Good knowledge of good clinical practices
Knowledge of applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
Legally authorized to work in India

Benefits

Comp & perks

Flexible work schedule
Permanent full-time position
Ongoing learning and development
Attractive advancement opportunities
Home-based work arrangement in India