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 assigned trials to ensure documentswhich fail TMF quality control and/or TMF quality review areeffectively remediated.
  • Closes and reassignsQIs as necessary.
  • eTMF Health: Manage ExpectedDocument Lists (EDL) and counts for the life of assigned trialspartnering with the Clinical Trial Team (CTT) and CROteam.
  • Escalate noncompliance with EDL businessprocess to the eTMF Manager as needed.
  • eTMFHealth: Provide scheduled and adhoc analysis and metrics on TMFHealth for eTMF Managers and CTT/CRO teams on assignedtrials.
  • Be responsible for TMF activities forassigned trials including:
  • Supporting TMFdocument filing into Moderna eTMF system.
  • Maintaining the naming and filing guide specific to TMFdocuments.
  • Conducting adhoc quality checks andreview of document content uploaded into theeTMF.
  • Responding to inquiries regarding TMFmanagement and contents.
  • Supportinginspection/audit preparation and remediationactivities.
  • Attend departmental andtrialspecific meetings and discussions asrequired.
  • Maintain up to date knowledge of theTMF Reference Model industry best practices and regulatoryrequirements.
  • Performs general administrativetasks related to their assigned trials.
  • Completes other TMF documentrelated tasks as required by the eTMFManager or department head.

Qualifications:

Minimum B.A./B.S. degree preferably in science orhealthcare.

2 years work experience preferablyin a relevant clinical research setting.

1years experience in eTMF document management (in a specialized teamor as a member of a clinical trial team) is an advantage.

Strong organizational/prioritization skills for themanagement of workload and attention to detail.

Why ICON

Our focus is to provide you with a comprehensive andcompetitive total reward package that comprises not only anexcellent level of base pay but also a wide range of variable payand recognition programs. In addition our best in class employeebenefits supportive policies and wellbeing initiatives are tailoredto support you and your family at all stages of your career bothnow and into the future.

Our success depends onthe knowledge capabilities and quality of our people. Thats why weare committed to developing our employees in a continuous learningculture one where we challenge you with engaging work and whereevery experience adds to your professional development.

ICON including subsidiaries is an equal opportunity andinclusive employer and is committed to providing a workplace freeof discrimination and harassment. All qualified applicants willreceive equal consideration for employment without regard to racecolour religion sex sexual orientation gender identity nationalorigin disability or protected veteran status.

If because of a medical condition or disability you need areasonable accommodation for any part of the application process orin order to perform the essential functions of a position pleaselet usknow.

Lifelancer( ) is a talenthiring platform in Life Sciences Pharmaand IT. The platform connects talent with opportunities in pharmabiotech health sciences healthtech data science and ITdomains.

Please use the below Lifelancer linkfor job application and quickerresponse.

/jobs/view/28e46c5d258db61aa47dba1d46efe928

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