3 Tmf Reviews Jobs

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3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a Senior Document Management Associate (DMA) at Advanced Clinical, you will be instrumental in maintaining the Trial Master File (TMF) to ensure the smooth progress of clinical trials. Your duties will include: - Creating study-specific TMF Plans and Indexes - Processing TMF documents in compliance with industry standards - Conducting TMF Reviews - Delivering internal and external TMF training You will collaborate closely with the TMF Manager to devise TMF Plans and Indexes, process TMF documents through classification, metadata indexing, and Intake QC reviews. Furthermore, you will conduct TMF Reviews according to the TMF Plan, rectify missing documents, and monitor pending tasks. Effect...

Posted 1 week ago

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2.0 - 6.0 years

0 Lacs

karnataka

On-site

The Senior Document Management Associate (SDMA) will provide support for Trial Master File (TMF) activities to the clinical teams for all assigned projects. This role will be responsible for working with study teams, both internal and external, to manage both paper and electronic Trial Master Files (TMF), according to project requirements, ICH GCP guidelines, local/global regulatory requirements and Novotech/Client SOPs. The SDMA will also be responsible for performing comprehensive QC reviews. Minimum Qualifications & Experience: - At least more than 2 years of experience in a clinical research organization or equivalent role. - Practical experience in handling Trial Master File activities ...

Posted 3 months ago

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3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a Senior Document Management Associate (DMA) at Advanced Clinical, you will play a crucial role in the maintenance of the Trial Master File (TMF) to ensure the smooth conduct of clinical trials. Your responsibilities will include creating study-specific TMF Plans and Indexes, processing TMF documents according to industry standards, conducting TMF Reviews, and providing internal and external TMF training. You will collaborate closely with the TMF Manager to develop TMF Plans and Indexes, process TMF documents by classifying them, indexing metadata, and performing Intake QC reviews. Additionally, you will conduct TMF Reviews as per the TMF Plan, address missing documents, and follow up on ...

Posted 3 months ago

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