TMF Document Coordinator I

Job not on LinkedIn

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• 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

• 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

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