Lead TMF Specialist

3 days ago

Bengaluru, India Lifelancer Full time

About thejob

Overview

TheEmmes Company LLC (Emmes) is a global fullservice Clinical ResearchOrganization dedicated to excellence in supporting the advancementof public health and biopharmaceutical innovation. We believe inthe power of truth so much so that we named our company Emmes whichmeans truth. Through decades of experience we have learned thatcollaborative relationships thrive and human health benefits whentruth is our compass.

Our Character AchievesResults culture is driven by five key values that guide our actionsin the way we conduct research and distinguish us as anorganization: Integrity Agility Passion for ExcellenceCollaborative Partnerships and Intellectual Curiosity. We are atrusted partner to clients who share our passion for improvingpublic health in a world of everchanging scientificresearch.

If you share our motivations andpassion in research come join us You will be joining acollaborative culture that empowers every Emmes employee from entrylevel through top executive to contribute to our clients success bysharing ideas openly andhonestly.

Responsibilities

  • Performs key TMF system administrator role and duties in accordancewith the company guidelines and work instructions (e.g. TMF setupquality management reports and metrics TMF quality control (QC)/quality assurance (QA) activitiesetc.).
  • Accountable for the overall TMF qualityand completion including appropriate document filing andmaintenance crossfunctional document coordinationincluding thirdparty documents and TMF tracking and reporting to internal andexternal customers.
  • Ensures the TMF filestructure follows applicable company approved TMF configurationregarding ICH Guidelines for Good Clinical Practice GoodDocumentation Practices and the TMF Reference Model asrequired.
  • Performs quality checks on juniorstaffs work.
  • Ensures that all new and updatedrecord information is accurately entered in the appropriate recordsmanagement databases such as RTS and eTMF eeva Vault for inspectionreadiness and highest quality of documentgovernance
  • Ensures that all assigned recordsare maintained in accordance with the company eTMF and/or otherelectronic data room storage SOPs processes and datastructure.
  • Develops and maintains companysdigital records/TMF training materials and guidelines and performstraining and/or coaching of new and existing staff asrequired.
  • Leads project staff in tracking thatessential documents are received and maintained across assignedstudies and sites.
  • Provide support in thereview of Informed Consents (ICFs) on a projectby project basis.May share this responsibility with Regulatory Affairs depending onlegacy or future contract proposals.
  • Verifiesreceipt reviews for identification and consistency sorts separatesphotocopies prints scans indexes labels and files a variety ofclinical TMF and other nonclinical documents asassigned.
  • Ensures customer requests forretrieval reproduction and refiling of requested records orelectronic images (e.g. PDF jpeg) are met in a timelymanner.
  • Manages activities for offsitearchival of clinical and TMF records.
  • Attendsand presents at outside conferences to assure currency of knowledgeand shares information learned at project or corporate rolemeetings.
  • May contribute to scientificmanuscripts and presentations.
  • Collaborateswith CRAs and CSMs to provide updates and support on an as neededbasis.
  • Other duties asassigned

Qualifications

  • Bachelorsrequired preferably in scientific discipline.
  • Masters degree preferred.
  • 7 years or more ofexperience with electronic Trial Master Files (eTMF) solutionshighly preferred
  • Extensive knowledge of GoodClinical Practices (GCP) and TMF governing regulations such as DIAReference Model.
  • Thorough understanding ofrecords management requirements in DrugDevelopment.
  • Experience with coordinatingdocument management activities performed by third parties such asclinical vendors.
  • Universal knowledge ofclinical research concepts and able to work in a teamenvironment.
  • Experience in linemanagementand/or mentoring less experienced Trial Master Filestaff.
  • Excellent organizational and planningskills.
  • Ability to build and maintain positiverelationships with management peers andsubordinates.
  • Excellent written and verbalskills required.
  • Display strong analytical andproblemsolving skills.
  • Has strong capacity tosynthesize information from one protocol to another on the sameproject. Applies knowledge learned from external meetings toimprove project or corporate activities.
  • Workson complex problems of diverse scope in which analysis ofsituations or data requires an evaluation of intangiblevariables.

Please usethe below link for job application and quickerresponse.


RemoteWork :

No

  • TMF Lead

    2 weeks ago

    Bengaluru, Karnataka, 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 Specialist II

    4 weeks 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

    2 weeks ago

    Bengaluru, Karnataka, India Allucent Full time

    At AllucentTM, we are committed to helping small-medium biopharmaceutical companies effectively navigate the complex world of clinical trials to deliver life-changing therapies to patients globally.We are seeking a Trial Master File Specialist II (TMFS II) to join our exceptional team. The TMF Specialist II oversees the organization of documents within the...

  • Lead TMF Specialist

    2 weeks ago

    Bengaluru, Karnataka, India Lifelancer Full time

    About the job Overview The Emmes Company, LLC (Emmes) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned...

  • TMF Lead

    4 weeks 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

    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 TMF Lead to join our A-team (hybrid*). As a TMF Lead at Allucent, you are responsible for coordinating the management of trial...

  • Lead TMF Specialist

    2 weeks ago

    Bengaluru, Karnataka, India Lifelancer Full time

    About the JobOverviewThe Emmes Company LLC is a global organization dedicated to supporting public health and biopharmaceutical innovation. Our core values of Integrity, Agility, Passion for Excellence, Collaborative Partnerships, and Intellectual Curiosity drive our culture. We are committed to improving public health through collaborative research.If you...

  • TMF Specialist II

    1 week 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 week 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 Lead I

    2 weeks ago

    Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd 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...

  • TMF Specialist

    2 weeks ago

    Bengaluru, Karnataka, India Lifelancer Full time

    About the job TMF Specialist is to perform all duties related to the timely processing of essential and non-essential clinical trial documents to facilitate study startup, drug shipment, eTMF maintenance and support eTMF inspection readiness activities Location : Bangalore/Chennai Experience Skills Ability to interact with Clinical and Regulatory team...

  • TMF Specialist

    2 weeks ago

    Bengaluru, Karnataka, India Lifelancer Full time

    About the jobAs a TMF Specialist, your main role is to handle all responsibilities related to the prompt processing of crucial clinical trial documents to help with study initiation, drug delivery, eTMF upkeep, and support eTMF inspection preparedness tasks.Location: Bangalore/ChennaiExperience & SkillsCapable of collaborating with the Clinical and...

  • TMF Specialist

    1 week ago

    Bengaluru, India Lifelancer Full time

    About thejobTMF Specialist is to performall duties related to the timely processing of essential andnonessential clinical trial documents to facilitate study startupdrug shipment eTMF maintenance and support eTMF inspectionreadiness activitiesLocation :Bangalore/ChennaiExperienceSkills Ability to interact withClinical and Regulatory team regarding the...

  • Specialist /Sr Specialist, TMF Project Management

    4 weeks ago

    Bengaluru, India Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Purpose: The Trial Master File (TMF) Project Management Assistant at Lilly Capability Center India (LCCI) serves in a key role for the execution of TMF Operations processes and administration. Provides process support for TMF creation, maintenance, closure and...

  • Intern - Accounting & Tax

    2 months ago

    Bengaluru, India TMF Group Full time

    **About TMF Group** TMF Group is a leading global provider of high-value business services to clients operating and investing globally. We focus on providing specialized and business-critical financial and administrative services that enable our clients to operate their corporate structures, finance vehicles and investment funds in different geographical...

  • Intern - Company Secretary

    3 weeks ago

    Bengaluru, India TMF Group Full time

    **About TMF Group** **TMF Group** is a leading global provider of high-value business services to clients operating and investing globally. We focus on providing specialized and business-critical financial and administrative services that enable our clients to operate their corporate structures, finance vehicles and investment funds in different...

  • HRp - Executive

    4 weeks ago

    Bengaluru, India TMF Group Full time

    **About TMF Group** TMF Group is a leading global provider of high-value business services to clients operating and investing globally. We focus on providing specialized and business-critical financial and administrative services that enable our clients to operate their corporate structures, finance vehicles, and investment funds in different geographical...

  • Executive - Accounting & Tax

    3 weeks ago

    Bengaluru, Karnataka, India TMF Group Full time

    **Job no**: 570710 **Work type**: Full time **Location**: Bangalore, India **Categories**: Client Accounting **Office Location**: Bangalore **About TMF Group** TMF Group is a leading global provider of high-value business services to clients operating and investing globally. We focus on providing specialized and business-critical financial and...

  • Executive - Accounting and Taxation

    2 weeks ago

    Bengaluru, Karnataka, India TMF Group Full time

    **Job no**: 570711 **Work type**: Full time **Location**: Bangalore, India **Categories**: Client Accounting **Office Location**: Bangalore **About TMF Group** TMF Group is a leading global provider of high-value business services to clients operating and investing globally. We focus on providing specialized and business-critical financial and...

  • Intern - Accounting & Taxation

    1 week ago

    Bengaluru, Karnataka, India TMF Group Full time

    **Job no**: 570629 **Work type**: Intern **Location**: Bangalore, India **Categories**: Client Accounting **Office Location**: Bangalore **About TMF Group** **TMF Group** is a leading global provider of high-value business services to clients operating and investing globally. We focus on providing specialized and business-critical financial and...