Job details

4.4

Document Specialist

Career level
Entry (0-2 years), Middle (2-5 years)
Employment type
Full time
Spoken languages
English - Advanced
* all languages are compulsory
Address
Number of vacancies
1

Who we are?

Cmed is an international technology-led contract research organization whose values include customer service and innovation. This is a very exciting time to join us as we are engaging with many new clients, using our cutting-edge technology, encapsia™ to help reduce the costs and increase the efficiency and speed of developing new medicines.

We are now looking for a competent and enthusiastic Document Specialist to join our document management team, in Timisoara.

THE ROLE

Cmed are pioneering new ways to manage and visualize Clinical Trial Data and we are looking for a committed, talented and effective Document Specialist to help make this change a reality for Cmed and our clients.

In a nutshell, the Document Specialist works cross-functionally with both internal departments and external contributors on Clinical Documentation topics and oversees the Trial Master File.

This is an entry level role and a great opportunity for recent graduates wanting to start a career in Clinical Research!

Key responsibilities

  • Ensures a complete, accurate and high-quality Trial Master File (TMF) as the single point of contact for the internal and external study team
  • Maintains a close and proactive relationship with the study team
  • Management of electronic Trial Master file documentation and paper Case Report Forms: TMF setup, conduct and close out activities
  • Accurate, timely and consistent handling of paper and electronic clinical trial documentation
  • Adherence to processes and procedures as documented in relevant Standard Operating
  • Procedures and related documents
  • Participates in preparation of TMF documentation related to audits and inspections
  • Administrative tasks: reports, eTMF system maintenance (user access, address eTMF related queries)
  • Supports TMF process development and implementation
  • Maintain compliance with company requirements (., time tracking, training)

Qualifications and attributes

  • Good MS office knowledge, particularly Excel and Word
  • Good organisational skills, attention to details
  • A science or health related university degree and experience working in a document management environment would be highly advantageous
  • Ability to work calmly under pressure and prioritise workload
  • Good communication skills
  • An investigative and meticulous approach to all activities and tasks
  • Advanced English level required

What we offer:

  • Mentorship and training to develop your skills in the clinical trials industry
  • The chance to be part of an effective, dynamic, friendly, and supportive team
  • Work with new and exciting technologies
  • Competitive salary and benefits
  • Clear career path and development opportunities

 

For more information on Cmed Recruitment and consideration for other opportunities, please review the recruitment statement on our careers page ().

Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Cmed HR or Recruitment Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Cmed may directly contact for employment application.