General Information

Location: Durham, NC, Remote

Organization: VeraSci

Job Type: Full Time - Regular

Description and Requirements

JOB SUMMARY:   
The Quality Manager, Global Language Services, is responsible for developing and overseeing the cognitive debriefing services offered by the department, implementing the quality management plan for all translated materials, and providing training for staff as needed. The Translation Quality Manager will manage the translations for sponsor projects as assigned, working with other internal departments to ensure sponsor needs are met.

Vaccination Requirement:

To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.



EDUCATION REQUIREMENTS: 

Bachelor’s Degree or equivalent.

QUALIFICATIONS/EXPERIENCE: 


  • 5 years’ experience in a clinical translations’ environment (CRO, pharmaceutical company, or other centralized service provider used in clinical studies) with an emphasis on the quality aspects of translations in this environment and the impact on clinical trials.
  • 5 years of demonstrated experience in managing projects in clinical trials with strong understanding of the project life cycle.
  • Experience performing or managing cognitive debriefing activities for Patient Reported Outcome assessments.
  • Experience in translations QA system development. 
  • Demonstrated ability to manage and execute projects on time and within budget.
  • Strong organizational and time management skills.
  • Ability to support and build collaborative working relationships both internally and externally.
  • Clear and concise in verbal and written communication, fosters smooth flow of timely and relevant information
  • Ability to see the big picture as well as work hands-on. 
  • Ability to proactively recognize project challenges and collaboratively implement effective action plans.
  • Excellent organizational and planning skills with the ability to utilize technology and tools to enhance the effectiveness of deliverables and service.
  • Ability to function effectively in a fast-paced environment and manage multiple projects simultaneously.
  • Proficient knowledge of MS Office, specifically Word, Excel, PowerPoint and MS Project and the ability to produce detailed reports and presentations using these tools.
  • 2nd language preferred

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required. 

  • Identify, qualify, and secure vendors (cognitive debriefers) for third party services
  • Consult with internal scientific department to develop cognitive debriefing questionnaires for Patient Reported Outcomes.
  • Consult with vendors to ensure quality implementation and strict adherence to timeline on all projects.
  • Effectively work with internal departments to ensure the quality and timeliness of translation work.
  • Serve as resource/subject matter expert for internal teams regarding linguistic validation.
  • Review and approve invoices.
  • Develop quality management plans for projects.
  • Work with QA to support process improvement and the development of SOPs that drive efficiencies to reduce project timelines and maintain or enhance quality. 
  • Implement and continuously improve quality management practices.
  • Participate in sponsor meetings, as required.
  • Mentor and train supporting resources.
  • Provide updates on project activity to Senior Management as required.
  • Lead special projects and initiatives as identified by Senior Management.
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
 

TRAVEL REQUIREMENTS:  
☐ 0% – 5% x☐ 5% - 10% ☐ 10% - 20% ☐ 20% - 50% ☐ >50% 



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