TMF Specialist (m/f)

Frankfurt am Main  ‐ Vor Ort
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Beschreibung

Our client is currently looking for a TMF Specialist (m/f) for a project in Hessen (exact city to be determined).

Description:

The purpose of this role is to support global standards for clinical trials records management activities at a country level serving as liaison between Records Management and user teams such as Clinical Operations.

Ensure that project timelines are met while facilitating the orderly transfer and quality control of clinical trials business records.

  • Manage documentation associated with clinical trials, both in paper and electronic format, including transitions and conversions.
  • Follow records management tasks, policies and procedures protecting record integrity by ensuring full compliance to GCP principles and client SOPs.
  • Perform audit and quality control checks on paper based studies and Electronic Data Capture systems.
  • Create and maintain filing structure for all the regulatory INDs, NDAs, CTAs, DMFs and SBAs
  • Fulfil company-wide requests for documents, records, and study reports
  • Liaise with study teams to coordinate the flow of trial documentation to the Records Center
  • Support project teams and functions in the preparatory activities for sponsor audits and regulatory inspections.
  • Conduct and manage electronic Trial Master File (eTMF) processes and train staff and deliver presentations regarding eTMF policies and procedures to disseminate knowledge and increase compliance.
  • Maintain logs and indexes to ensure information status is audit ready at all times and assist in the collection of data Manage and oversee the external archiving providers, including tracking of documents between Client and the external archive

Skills:

  • Experience in using electronic document management system (First Doc ? Documentum), including QC approval of workflows and uploading Receive, process and track all clinical project related paper and electronic documents including global study and site documents.
  • Understand clinical trial processes and needs Excellent organizational skills and time management 
  • Good attention to detail Work under pressure and to deadlines Pro- active, flexible and able to multi-task 
  • Self-motivation 
  • Work in a team and independently 
  • Excellent communication and influencing skills 
  • IT literacy, particularly in Word, Excel and PowerPoint 
  • University degree or equivalent in health sciences, nursing or pharmacy or related field Previous experience of working in Clinical Research or the Pharmaceutical Industry
  • Knowledge of the Industry/Clinical trial process and drug development Knowledge of ICH GCP and Trial Master File
Required languages: German and English

Location: Hessen exact city to be determined

Duration: asap ? 31.12.2016

If this is of interest to you, please send us your CV (incl. all necessary contact details [name, address, telephone numbers, Email]) referring to the project name and relevant contact person. Please refrain from sending several attachments. We would appreciate any info concerning your availability and rate expectations. We look forward to receiving your application.

Start
09.2016
Dauer
1 Monate
Von
Experis GmbH
Eingestellt
30.09.2016
Ansprechpartner:
Vesna Stajic
Projekt-ID:
1213018
Vertragsart
Freiberuflich
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