TransPerfect

Clinical Document Specialist

ID
2014-4602
Category
Quality Assurance/Compliance
US-NY-New York

Responsibilities

The Clinical Document Specialist is responsible for maintaining the quality of client Trial Master File integrity and assisting in the periodic audits of TMF contents. The CDS will also be responsible for keeping up to date SOPs regarding TMF management. The candidate will be required to meet all client timelines and work in conjunction with the operations team as well as the global document management team. 

  • Responsible for Trial Master File (TMF) quality for sponsor and/or CRO studies
  • Assist in Periodic audits of client TMFs as well as internal TMF audits
  • Prepare, process and track paper & electronic documents received as per project guidelines in a timely manner
  • Ensure documents are scanned, imported, coded, and indexed into the (e)Trial Master File and reviewed for quality on an ongoing basis 
  • Archive all paper files and maintain an ongoing inventory list of all received files as per guidelines.
  • Liaison with internal and regional teams to ensure completeness and quality of documents 
  • Plan and perform periodical quality checks of (e)Trial Master Files & the Paper TMF Files to identify any filing issues experienced by the Clinical Trial Teams to ensure that both (e)Trial Master Files and Paper TMF Files meet internal and external quality standards
  • Assist in writing and editing SOPs to keep current with industry changes on TMF management, quality and archival
  • Assist in Training team members as well as other TransPerfect Life Sciences Production teams on essential documents and regulatory requirements
  • Participate in and become an expert on the TMF Reference Model and stay current on regulatory changes
  • Take a proactive role in learning about clients' industries, business needs and company culture, educating the project team, identifying new business opportunities and providing a high level of service
  • Ultimately responsible for submission and inspection readiness of the TMF

Qualifications

  • Minimum Associate Degree in Science, Preferred BS from 4-year college or equivalent
  • Minimum 3 years experience in the life sciences industry
  • Knowledge of clinical development phases and processes including GCP and ICH regulations
  • Previous employment in Pharmaceutical, CRO or Medical Device industry
  • Previous experience overseeing TMF audits, internal and/or regulatory audits
  • Experience collecting, scanning and coding TMF documentation
  • Experience in overseeing and training employees on TMF SOPs and regulatory requirements
  • Superior written and spoken communication skills in English.
  • Proficiency in Adobe Acrobat Professional, ISI Tools and web-base document indexing and viewing application. Knowledge of scanning, extracting, uploading, OCR, rendering, bookmarking/linking, document verification and compiling
  • Proficiency in Microsoft Office (Word, Excel, Outlook), eTMF and eClinical technologies

Desired Skills:

  • Able to multitask in a fast-paced environment
  • Works well with people from a variety of different backgrounds and cultures
  • Builds relationships with clients and co-workers
  • Can work independently and as part of a team
  • Takes active measures to solve problems and commit to a high level of service.

Overview

For over 20 years, TransPerfect has provided comprehensive language and technology solutions to help our clients communicate and conduct business more effectively in a global marketplace. Equipped with a quality management system certified to both the ISO 9001:2008 and EN 15038:2006 standards, TransPerfect provides a full array of language and business support services, including translation, interpretation, multicultural marketing, website globalization, subtitling, voiceovers, staffing services, multicultural marketing, training and learning, and legal support services. TransPerfect also offers a suite of cutting edge technologies that significantly reduce costs and improve consistency throughout the translation process, making TransPerfect the vendor of choice for the world's leading multinationals.

 

With annual revenues of over $500 million, TransPerfect is the world's largest privately held provider of language services and technology solutions. From offices in more than 90 cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and EN 15038 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong.

 

TransPerfect offers a comprehensive benefits package including: medical, dental, vision, 401k, paid time-off, company sponsored life insurance, short term and long term disability, flexible spending account options, and a pro-active and accessible HR department that focuses on the staff’s health and happiness.

 

TransPerfect is an equal opportunity employer.

 

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