TMF Specialist

1 month ago

Bengaluru, India Lifelancer Full time

About thejob

Overview

The Emmes Company LLC (Emmes) is a global fullserviceClinical Research Organization dedicated to excellence insupporting the advancement of public health and biopharmaceuticalinnovation. We believe in the power of truth so much so that wenamed our company Emmes which means truth. Through decades ofexperience we have learned that collaborative relationships thriveand human health benefits when truth is our compass.

Our Character Achieves Results culture is driven by fivekey values that guide our actions in the way we conduct researchand distinguish us as an organization: Integrity Agility Passionfor Excellence Collaborative Partnerships and IntellectualCuriosity. We are a trusted partner to clients who share ourpassion for improving public health in a world of everchangingscientific research.

If you share ourmotivations and passion in research come join us You will bejoining a collaborative culture that empowers every Emmes employeefrom entry level through top executive to contribute to our clientssuccess by sharing ideas openly and honestly.

Primary Purpose

The Trial Master File (TMF) Specialist is responsible forthe overall management quality and maintenance of essentialclinical trial and other designated documents including the set upand maintenance of the TMF with a strong focus on ensuring thatroutine document management operations are performed with adherencewith SOPs (Project and Corporate) and ICH/GCP/TMF guidelines. Thisposition plays a key role in both paper and electronic global TMFsystem management by filing organizing and maintainingpaper and/ordigital records and coordinating the document management activitiesperformed by third parties such as vendors clinical sitescollaborators as well as other internal and external team membersas required.

Responsibilities

  • Performs key TMF Specialist duties inaccordance with the company guidelines and work instructions (e.g.TMF setup quality management reports and metrics TMF qualitycontrol (QC)/ quality assurance (QA) activitiesetc.)
  • Accountable for the overall TMF qualityand completion including appropriate document filing andmaintenance crossfunctional document coordination including thirdparty documents and TMF tracking and reporting to internal andexternal customers
  • Ensures the TMF filestructure follows applicable company approved TMFconfigurationregarding ICH Guidelines for Good Clinical Practice GoodDocumentation Practices and the TMF ReferenceModel
  • Ensures that all new and updated recordinformation is accurately entered in the appropriate recordsmanagement databases and is maintained in accordance with thecompany eTMF and/or other electronic data room storage SOPsprocesses and data structure for inspection readiness under minimumsupervision
  • Ensures customer requests for TMFretrieval reproduction and refiling of requested records orelectronic images (e.g. PDF jpeg) are met in a timelymanner
  • Classify and add metadata to uploadeddocument (Site Level docs uploaded by iCRA Country level docsuploaded by SME and Study/Trial level docs uploaded by SME); mayupload documents as required
  • QC review andapprove documents to ensure that all new and updated documents areaccurately entered in the appropriate records management databasesfor inspection readiness
  • Proactively assistsproject staff in tracking that essential documents are received andmaintained across assigned studies and sites; may interfacedirectly with sites to complete all document collections and checkfor accuracy
  • Assists with the development andmaintenance of the companys digital records/TMF training materialsSOPs and guidelines and may perform trainingand/or coaching of newand existing staff as required undersupervision
  • May run project specific metricsidentifies trends risks and associated actions for assignedprojects
  • Assists with activities for transferdelivery and offsite archival of TMF records under minimalsupervision
  • May assist with audit/inspectionpreparation
  • May assist with reviewing updatesto project TMF Plans Filing Guidance and WorkInstructions
  • May assist in site activation andmaintenance activities including collecting and reviewing essentialdocuments from clinical sites
  • May collaboratewith project team to ensure all appropriate documents have beenfiled prior to specific study milestones (e.g. site activationamendments closeout and TMF delivery)
  • May beresponsible for tasks associated with posting studies toClinicalTrials.gov
  • Other duties asassigned

Qualifications

  • Bachelors required preferably in scientificdiscipline
  • 23 years of experience in relevantdocument management preferred
  • 1 year or moreof experience with electronic Trial Master Files (eTMF) systemshighly preferred especially Veeva Vault
  • Experience with coordinating document management activitiesperformed by third parties such as clinicalvendor
  • Knowledge of clinical researchconcepts
  • Working knowledge of Good ClinicalPractices (GCP) and TMF governing regulations such as TMF ReferenceModel
  • Thorough understanding of recordsmanagement requirements in Drug Development
  • Ability to access technical information and read study materialssuch as protocols MOPs and User Guides critically and identifyareas of inconsistency and other quality issues and makerecommendations for improvement
  • Ability tobuild and maintain positive relationships with management peers andsubordinates and able to work in a teamenvironment
  • Excellent organizational andplanning skills including strong attention todetail
  • Excellent written and verbal skillsrequired
  • Display strong analytical andproblemsolving skills
  • Demonstrates capacity tosynthesize information from one protocol/technical task to anotheron the same project
  • May provide task specificmentorship to projectstaff

Please use thebelow link for job application and quickerresponse.


RemoteWork :

No

  • TMF Specialist II

    1 month ago

    Bengaluru, India Allucent Full time

    At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for The Trial Master File Specialist II (TMFS II) to join our A-team (hybrid*). TMF Specialist II coordinates the indexing of...

  • TMF Specialist II

    1 month ago

    Bengaluru, India Allucent Full time

    At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for The Trial Master File Specialist II (TMFS II) to join our A-team (hybrid*). TMF Specialist II coordinates the indexing of documents...

  • TMF Specialist II

    3 weeks ago

    Bengaluru, India Lifelancer Full time

    About thejob As a (TMF Specialist II) youwill be joining the worlds largest most comprehensive clinicalresearch organisation powered by healthcare intelligence.Responsibilities: Maintain effective communication with clinicaltrial teams and CRO staff throughout trial startup maintenancecloseout and archive eTMF Health: Manage openQuality Issue (QI) lists for...

  • TMF Lead

    3 months ago

    Bengaluru, India Allucent Full time

    At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for TMF Lead to join our A-team (hybrid*). As a TMF Lead at Allucent, you are responsible for coordinating the management of trial...

  • TMF Lead

    3 months ago

    Bengaluru, India Allucent Full time

    At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for TMF Lead to join our A-team (hybrid*). As a TMF Lead at Allucent, you are responsible for coordinating the management of trial...

  • Sr. Specialist

    3 weeks ago

    Bengaluru, India TMF Group Full time

    We never ask for payment as part of our selection process, and we always contact candidates via our corporate accounts and platforms. If you are approached for payment, this is likely to be fraudulent. Please check to see whether the role you are interested in is posted on our career website. About TMF Group TMF Group is a leading global provider of...

  • Sr. Specialist

    3 weeks ago

    Bengaluru, India TMF Group Full time

    We never ask for payment as part of our selection process, and we always contact candidates via our corporate accounts and platforms. If you are approached for payment, this is likely to be fraudulent. Please check to see whether the role you are interested in is posted on our career website. About TMF GroupTMF Group is a leading global provider of...

  • Sr. Specialist

    3 weeks ago

    Bengaluru, India TMF Group Full time

    We never ask for payment as part of our selection process, and we always contact candidates via our corporate accounts and platforms. If you are approached for payment, this is likely to be fraudulent. Please check to see whether the role you are interested in is posted on our career website. About TMF GroupTMF Group is a leading global provider of...

  • Accounts Payable Specialist

    3 weeks ago

    Bengaluru, India TMF Group Full time

    We never ask for payment as part of our selection process, and we always contact candidates via our corporate accounts and platforms. If you are approached for payment, this is likely to be fraudulent. Please check to see whether the role you are interested in is posted on our career website. About TMF Group TMF Group is a leading global provider of...

  • Accounts Payable Specialist

    3 weeks ago

    Bengaluru, India TMF Group Full time

    We never ask for payment as part of our selection process, and we always contact candidates via our corporate accounts and platforms. If you are approached for payment, this is likely to be fraudulent. Please check to see whether the role you are interested in is posted on our career website. About TMF GroupTMF Group is a leading global provider of...

  • Accounts Payable Specialist

    3 weeks ago

    Bengaluru, India TMF Group Full time

    We never ask for payment as part of our selection process, and we always contact candidates via our corporate accounts and platforms. If you are approached for payment, this is likely to be fraudulent. Please check to see whether the role you are interested in is posted on our career website. About TMF GroupTMF Group is a leading global provider of...

  • Accounts Payable Specialist

    3 weeks ago

    Bengaluru, India TMF Group Full time

    We never ask for payment as part of our selection process, and we always contact candidates via our corporate accounts and platforms. If you are approached for payment, this is likely to be fraudulent. Please check to see whether the role you are interested in is posted on our career website.About TMF GroupTMF Groupis a leading global provider of high-value...

  • Sr. Specialist

    3 weeks ago

    Bengaluru, India TMF Group Full time

    We never ask for payment as part of our selection process, and we always contact candidates via our corporate accounts and platforms. If you are approached for payment, this is likely to be fraudulent. Please check to see whether the role you are interested in is posted on our career website.About TMF GroupTMF Groupis a leading global provider of high-value...

  • Specialist Software Engineering

    3 months ago

    Bengaluru, India AT&T Full time

    Job Description : About Organization/Team CIO-IDC is responsible for advancing information technology performance and delivering technical solutions with a focus on return on investment and increasing efficiency while improving quality and enhancing the experience of end users. The Site Reliability Engineering Team is composed of 10 Site...

  • Solution Architect Specialist

    2 months ago

    Bengaluru, India BT Group Full time

    What you’ll be doing  Must have working experience of Network OSS Solution Architecture in one or more of Network OSS sub-domains like (1) Infrastructure Plan & Build, (2) Network Inventory Management, (3) Business Process & Workflow Management, (4) Network & Service Activation/Provisioning, (5) Service & Resource Orchestration/Fulfilment.  Must...

  • Specialist Engineer

    4 weeks ago

    Bengaluru, India BT Group Full time

    What you’ll be doing Technical Expertise: Be a subject expert and drive shared learning and collaboration.  Leadership and Mentoring: Provide guidance, mentorship, and technical leadership to the assurance team and should foster a culture of continuous improvement, knowledge sharing, and collaboration within the team.  Continuous Learning: A...

  • Medical Reviewer

    3 months ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Medical Reviewer **Category**:Clinical Development**Location**:Bangalore, Karnataka, IN**Department - Centralised Monitoring Unit (CMU) - Bangalore**About the department** - The Centralised Monitoring Unit (CMU) - Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers)...

  • Startup Associate I

    3 months ago

    Bengaluru, Karnataka, India Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Head Quality Review, Clinical Development

    2 months ago

    Bengaluru, India Syngene Full time

    JOB DESCRIPTION Designation: Head Quality Control Review, Clinical Development Job Location: Semicon Park, Bengaluru Reporting to: Operating Unit Head, Clinical Development Job Grade: 5-II Company Overview  Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and...