TMF Specialist
Pharm-Olam
Bangalore, IN
5d ago

Overview

About Pharm-Olam International :

Pharm-Olam International is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace.

Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further.

We offer a unique working environment with a global team culture, competitive salary and benefits package.

Summary :

The TMF Specialist is responsible for Scanning, uploading, Indexing and reviewing documents filed in the eTMF. TMF Spcialist is responsible for verify eTMF Inspection Readiness to ensure clinical trials are conducted in accordance with ICH-GCP and applicable regulations.

Responsibilities

  • As a member of Global TMF Management, the TMF Specialist is expected to hold and contribute to process improvement with a focus on value to our business and meeting client needs
  • To liaise with study teams and other Global TMF Management staff in order to fulfil job responsibilities and activities with supervision
  • To obtain knowledge and skills to process study TMF documents in accordance with study requirements as per study-specific processes, Pharm-Olam SOPs / WIGs, GCP and regulations
  • Timely complete the activities related to document processing which includes : document receipt and review, scanning and indexing, quality control, filing, forwarding or return to client / study teams and archiving
  • To complete assignments in accordance with specified timelines, Pharm-Olam SOPs / WIGs, GCP and applicable regulations
  • To maintain study TMF files as per study and / or client requirements or in accordance with Pharm-Olam SOPs / WIGs and applicable regulations
  • To inform the TMF Manager of training issues, project activities, quality issues and timelines as directed
  • To participate in client and / or Pharm-Olam audits as necessary
  • To participate in document archiving activities as necessary
  • To participate in training related to fulfilment of responsibilities as required by Pharm-Olam and / or the client
  • Maintain regular and effective verbal and written communication with Pharm-Olam project team members
  • Attend training (including department-specific) sessions, as applicable.
  • Working relationships :

  • Report to Manager / designee in Global TMF Management department
  • Collaborate with Study TMF Lead, POI study teams and all Pharm-Olam.
  • Qualifications

  • APAC / India : Minimum of 1 year of clinical trial experience with clinical document management / administration experience a strong plus
  • EU / US region : Through knowledge and strong working experience on eTMF / TMF files management
  • Computer literate with experience in Microsoft Office suite.
  • Understanding of Pharm-Olam SOPs
  • Good written and verbal communication skills
  • Excellent interpersonal and organizational skills
  • Ability to work independently and to effectively prioritize tasks
  • Ability to manage multiple projects
  • Attention to detail.
  • Apply
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