Vacancies

GCP-Service is an independent full-service Clinical Research Organization which offers his clinical research services throughout Europe using the latest modern technologies. Since our foundation in 2004, the company has continuously grown enabling us to deliver the entire spectrum of services required for a successful conduct of clinical trials.

We love what we do and are convinced that our multiple innovative processes as well as our competences and continuous development of our employees provide unique advantages to our company, clients, partners and vendors.

Trial Master File (TMF) Manager (part-time / full-time) in Czech Republic

We are currently looking for a TMF Manager (w/m/d) to strengthen our Clinical Document Management team in our office in Prague.

The successful candidate will have the opportunity to work in a multidisciplinary team contributing to international clinical research projects. She/he will be in charge to manage (electronic/paper) TMFs and study documentation of clinical trials from start to end. She/he prepares and maintains the TMF to allow verification of the conduct of a clinical trial and the quality of the data generated.

Preferred qualifications:
  • B.Sc. or any equivalent qualification (e.g. Study Nurse, Document Specialist, etc.)
  • Excellent planning, organizational and time management skills
  • Attention to detail and the ability to work individually
  • Proficient computer skills including Microsoft Word, Excel, and PowerPoint
  • Proficient presentation skills (e.g. internal trainings)
  • Fluency in Czech & English
Responsibilities:
  • Serve as main administrator of the eTMF (including electronic Investigator Site File)
  • Manage study documents and ensure they are quality checked, correctly named and filed in TMFs in due time
  • Plan and perform periodical reviews of TMF files to assess their completeness and quality and communicate status updates to the study team to address and resolve any filing issues
  • Actively engage study teams and external resources to ensure the receipt, processing and tracking of all study-related documentation
  • Preparation and shipment of clinical study supplies and documents to study sites and sponsors
  • Provide TMF trainings to clients and study teams to ensure study documents are processed adequately and per SOP and study-specific TMF management plans
  • Prepare and ship the TMF for archiving according to statutory retention periods and requirements
  • Assist Project Managers and study teams in executing assigned clinical trial activities (e.g. create and maintain trackers, generate meeting minutes, etc.)
  • Assist the study team in the submission of clinical trial applications to Ethic Committees and Competent Authorities
  • Contribute to the continuous development of departmental procedures

If you are interested, send us your electronic application (with your earliest start date) and your CV to:

Ing. Kristýna Paseková
GCP-Service International s.r.o.
Pekarska 695/10b
155 00 Praha 5
Czech Republic
Mobile: +420 776 805 805
E-mail: kpasekova@gcp-service.com

We will be happy to give you more information during a personal meeting in our office Pekařská 10b, Praha 5.

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