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Job Details

Clinical Specialist: Trial Master File Expert (m/f)

Company: SynteractHCR Deutschland GmbH
Location: Brussels, Belgium
Reference: 26931
Closing Date: 20 Oct 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Clinical Specialist: Trial Master File Expert (m/f)   Overview The Trial Master File (TMF) Specialist supports the clinical study team proactively with full responsibility in all aspects of the maintenance and TMF process set up of the study TMF by supporting the Project Manager and document owners and addresses ad-hoc issues being  the Trial Master File (TMF) study owner.   Responsibilities Ensure high quality and up-to-date TMF management being embedded in...

Requirements:

Clinical Specialist: Trial Master File Expert (m/f)

 

Overview

The Trial Master File (TMF) Specialist supports the clinical study team proactively with full responsibility in all aspects of the maintenance and TMF process set up of the study TMF by supporting the Project Manager and document owners and addresses ad-hoc issues being  the Trial Master File (TMF) study owner.

 

Responsibilities

  • Ensure high quality and up-to-date TMF management being embedded in different clinical study teams
  • Own and maintain the study TMF management plan and ensures adherence by the study team members
  • Support the Project Manager in planning and executing TMF management-related activities of the clinical trial team in order to ensure that the TMF is in good shape and updated on a timely manner
  • Responsible to track eTMF-periodic reviews for studies and provide regular updates to the SDL/Head TMF Operations
  • Primary point of contact for study team members for any TMF-related question
  • In charge of the set-up of the TMF for each new study (on-boarding of study contributors, TMF plan, performing preparation of the documents in the system)
  • In charge, during the maintenance of the TMF that the contributors are providing their documentation on an in-stream basis (by running KPI, by running reports, by running QC checks if needed).
  • Proactively take the appropriate relevant actions to address gaps, issues and risks and make suggestions for improvement
  • Provide training to newcomers and refresher training to existing users
  • Collect study wet-ink paper documents, prepares the wet-ink documents for archiving, arrange shipments of those to the clinical archiving team for long term retention
  • Lead inspection/audit preparation related activities with regards to study-related documentation

 

Qualifications

  • Scientific degree or mix between administrative degree and relevant work experience
  • Relevant working experience in a pharmaceutical / scientific environment is a must as well as knowledge of clinical trials (including ICH-GCP) and exposure to document management
  • Expertise in project planning & project management is an asset
  • Ability to set and manage priorities, performance targets, multiple tasks and project initiatives in a global environment
  • Provide negotiation and presentation skills and be customer oriented
  • Ability to work independently, within a team in a matrix organization connecting with a broad range of cultures
  • Organized, methodical and attention to detail and conflict resolution

 

 

To apply

Have we sparked your interest? Then we are looking forward to receiving your application! Please apply through our homepage synteracthcr.com and state your earliest start date/notice period and your desired salary. If you have any questions regarding the position please contact antonia.schultze@Synteracthcr.com

 


Apply for this job: Clinical Specialist: Trial Master File Expert (m/f)

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

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