Lead TMF Specialist

3 weeks ago

bangalore, 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 :

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