Sr. TMF Specialist

Emmes Group

3 - 7 years

4 - 8 Lacs

bengaluru

Posted:10 hours ago| Platform:

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Skills Required

process automation change management manager quality assurance gcp project management analytical system integration clinical research manager quality control ophthalmology

Work Mode

Work from Office

Job Type

Full Time

Job Description

Acts as an SME on eTMF applications, TMF processes, document identification/filing and project team processes that result in TMF document generation/collection
Owns the TMF Plan/Index and leads the identification of expected documents by finding ways and means to stay abreast of the study events
Review the SoW to understand the scope of work and align TMF requirement to it
Delineate between in scope vs out of scope TMF activities
Build relationships with sponsor counterpart keeping Project Manager/Leader in loop to partner with them and provide inputs on best industry practices, especially if sponsor eTMF is used for assigned studies
Ensures the TMF file structure follows applicable company approved TMF configuration, regarding ICH Guidelines for Good Clinical Practice, Good Documentation Practices and the TMF Reference Model, as required
Contribute to mentoring and grooming TMF Specialists TMF related competencies
Represents TMF Operations during internal/external/sponsor audits and manage findings through effective resolution both operationally and within the Veeva Vault Contributes to SOPs (Project and Corporate), company guidelines, work instructions and templates (eg, TMF set-up, quality management, reports and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc) to ensure that TMF Operations tasks are performed in adherence with ICH/GCP/regulatory guidelines and best practices
Support implementation of features and contribute to change management related to usage of Veeva Vault eTMF system in conjunction with the Clinical Systems Manager
Acquires expertise in eTMF applications used for studies where sponsor eTMF is chosen as TMF repository
Contributes to streamlining the processes and implementing automation such as VBA macros, Robotic Process Automation (RPA), system integration, Artificial Intelligence (AI)/Machine Learning (ML)
Perform tasks within eTMF application to maintain the lifecycle of the TMF (eg, TMF set-up, EDL maintenance, reports and metrics, initiate/follow up/close out/perform periodic review, TMF close out/archival, etc) Overview Emmes Group: Building a better future for us all
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients
Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma
Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience
We believe the work we do will have a direct impact on patients lives and act accordingly
We strive to build a collaborative culture at the intersection of being a performance and people driven company

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