5.0 - 7.0 years

0 Lacs

india

On-site

JOB DESCRIPTION About The Role: The Clinical Document Specialist (CDS) will provide support for Trial Master File (TMF) activities to the clinical teams for assigned projects. This role will be responsible for the overall management and quality maintenance of essential clinical trial and other designated documents, including the set up and maintenance of the Trial Master File (TMF) The CDS will have a strong focus on ensuring routine document management operations are performed with adherence to Novotech SOPs. This role to manage Trial Master Files (TMF), both electronic and paper in format according to project requirements, ICH GCP guidelines, local/global regulatory requirements and Novote...

Posted 4 days ago

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Site Specialist II ICON plc

0.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Site Specialist II - India - Office with Flex ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Site Specialist II to join our high-performing and collaborative Site Activation team at ICON. As a Site Specialist II, you will play a critical role in the start-up, maintenance, and contract management activities for clinical trial sites. This is an exciting opportunity to work across essential site-level functions that support the timely and compliant activation...

Posted 1 month ago

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Senior Document Management Associate Advanced Clinical

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 month ago

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QC Specialist(eTMF) eClinical Solutions

2.0 - 5.0 years

0 Lacs

bengaluru, karnataka, india

On-site

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. Overview Trial Master File (TMF) Quality Control (QC) Specialist plays a critical role in ensuring the accuracy, completeness, and compliance of the TMF, which is the central repository of essential documents for a clinical trial. TMF Quality Control Specialists wi...

Posted 2 months ago

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