Associate TMF Specialist - Bengaluru (Emmes Group)
Location: India - Bengaluru
Department: Clinical Operations
Type: Regular Full-Time
Company: Emmes Group
About Emmes Group:
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discoveries closer to patients. Founded over 47 years ago, Emmes began as one of the primary clinical research providers to the US government, later expanding into public-private partnerships and commercial biopharma. Our expertise spans cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.
We are a performance-driven, people-centered company where collaboration and innovation thrive. If you're passionate about advancing clinical research and contributing to life-changing discoveries, join us!
Primary Purpose:
The Associate TMF Specialist is responsible for uploading and indexing TMF documents in eTMF or maintaining paper TMF documents. This role ensures that routine operations align with SOPs (Project and Corporate) and ICH/GCP/TMF guidelines.
Key Responsibilities:
Act as a subject matter expert (SME) on eTMF application features related to TMF operations, TMF processes, and document identification/filing.
Adhere to the TMF Plan/Index created by Lead/Senior TMF Specialist, ensuring TMF document collection is in line with the TMF Plan/Index.
Contribute to the identification of expected documents based on filed documents.
Ensure the TMF file structure follows company-approved TMF configurations, adhering to ICH Guidelines for Good Clinical Practice, Good Documentation Practices, and the TMF Reference Model.
Contribute to SOPs, company guidelines, work instructions, and templates (e.g., quality management, reports, metrics, TMF quality control (QC)/quality assurance (QA) activities) to ensure compliance with ICH/GCP/regulatory guidelines.
Support implementation of features of the Veeva Vault eTMF system in conjunction with the Clinical Systems Manager.
Acquire expertise in eTMF applications used for studies where sponsor eTMF is chosen as the TMF repository.
Contribute to streamlining processes and implementing automation such as VBA macros, Robotic Process Automation (RPA), system integration, Artificial Intelligence (AI), and Machine Learning (ML).
Perform tasks within the eTMF application to maintain the lifecycle of the TMF (e.g., EDL maintenance, reports, metrics).
Qualifications:
Education: Bachelor's degree, preferably in a scientific discipline.
Experience: 0 to 3 years of Clinical Operations/Filing documents experience in TMF Operations.
Technical Skills:
Knowledge of filing procedures and eTMF application is mandatory.
Experience in Veeva Vault is desirable.
Competent computer skills with the ability to adapt to new systems.
Regulatory Knowledge: Thorough understanding of GCP and TMF governing regulations, including the TMF Reference Model.
Preferred Experience: Exposure to NIH-sponsored clinical programs.
Key Attributes:
Strong organizational, planning, analytical, and problem-solving skills.
Attention to detail and ability to manage competing priorities.
Capability to work in a changeable environment and handle stressful situations.
Ability to build and maintain positive relationships with management, peers, and subordinates.
Excellent verbal and written communication skills with fluency in English.
High motivation, results-driven approach, and initiative.
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |New Jersey :
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Dún Laoghaire |Meath :
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China | Quarry Bay |Hubei :
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Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
Queensland |Remote Australia :
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Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |North Brabant :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
Buenos Aires |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Renfrew | North York | Uxbridge | Mississauga | Richmond Hill |Quebec :
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Croatia |Zagreb :
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North Ostrobothnia :
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Koropi | Athens |Greece :
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Netanya | Yavne | Tel Aviv | Kfar Saba | Be'Er Sheva |Italy :
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Japan | Saitama |Tokyo :
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Remote Korea |Republic of Korea :
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Remote - Europe | Remote, USA | Switzerland | Remote - Middle East | Remote | Remote - Africa | Remote - South America (Latin Americal) |Bucharest :
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Riyadh | King Abdullah Economic City | Rabigh | Khulais | Najran | Jeddah |Nišava District :
Niš |Singapore :
Singapore |South Africa :
Midrand | South Africa |Brazil :
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Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
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