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13 Emmess Services Jobs

Associate TMF Specialist

Emmes

0-3 years

Bangalore / Bengaluru

1 vacancy

Associate TMF Specialist

Emmess Services

posted 13d ago

Job Role Insights

Key skills for the job

Clinical Research Machine Learning Robotic Process Automation Analytical Chemistry GCP Macros

+ 1 more

Job Description

Acts as an SME on eTMF application features related to TMF Operations, TMF processes, document identification/filing
Adheres to the TMF Plan/Index created by Lead/Senior TMF Specialist and ensures that TMF document collection is in line with the TMF Plan/Index
Contributes to the identification of expected documents based on filed documents
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
Contributes to SOPs (Project and Corporate), company guidelines, work instructions and templates (e
g
, 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 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 (e
g
, EDL maintenance, reports and metrics, 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
We re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company
If you share our motivations and passion in research, come join us! Primary Purpose The Associate TMF Specialist is primarily responsible for uploading and indexing the TMF documents in eTMF or filing, organizing and maintaining documents in paper TMF with a strong focus on ensuring that routine operations are performed with adherence with SOPs (Project and Corporate) and ICH/GCP/TMF guidelines
Responsibilities Acts as an SME on eTMF application features related to TMF Operations, TMF processes, document identification/filing
Adheres to the TMF Plan/Index created by Lead/Senior TMF Specialist and ensures that TMF document collection is in line with the TMF Plan/Index
Contributes to the identification of expected documents based on filed documents
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
Contributes to SOPs (Project and Corporate), company guidelines, work instructions and templates (eg, 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 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 (e
g
, EDL maintenance, reports and metrics, etc
) Qualifications Bachelors degree requited, preferably in scientific discipline
Incumbent typically will possess 0 to 3 years of Clinical Operations/Filing documents experience in TMF Operations
Knowledge of filing procedures and eTMF application is mandatory
Experience in Veeva is desirable
Competent computer skills including ability to take on board new systems
Capability of managing competing priorities in a changeable environment and ability to handle stressful situations/deadlines
Thorough knowledge of GCP and TMF governing regulations, such as the TMF Reference Model required
Experience in NIH-sponsored clinical programs is a plus
Assertiveness, technical background, integrity
Good organizational, planning, analytical, and problem-solving skills
Attention to detail required
Ability to build and maintain positive relationships with management, peers, and subordinates
Excellent verbal and written presentation, communication skills along with fluency in English are necessary
Highly motivated, results driven with unyielding predisposition to detail and accuracy
Possess high degree of initiative
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