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eTMF specialist

Employer
Hobson Prior
Location
Switzerland
Salary
Up to £45.81 per hour + Up to CHF 55 per hour
Start date
25 Sep 2019
Closing date
22 Oct 2019

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Hobson Prior are currently working with a large pharmaceutical company who are currently recruiting for 3 eTMF Specialists to join them on a 6-month contract in Zurich. Our client is determined to deliver pioneering medicines to enable better health for patients around the world.

Job Responsibilities:

  • Complete an ongoing quality control of the eTMF and ensure its inspection readiness i.e. completeness and compliance with the relevant requirements from study start-up until archiving.
  • Provide regular eTMF process guidance on the eTMF related requirements according to the applicable SOPs, WIs, guidelines, eTMF management plan.
  • Provide practical support to eTMF users on the use of the system.
  • Escalate to the relevant functions any limiting factors and non-compliance related to the eTMF quality and provide comprehensive guidance on issue resolution.
  • Monitor the eTMF quality issues and follow up with the relevant functions (sponsor / vendor) until their resolution.
  • Deliver support by eTMF related audit or inspections.
  • Contribute to the revisions of the eTMF process and system enhancements.
  • Perform review of the eTMF management plans and provide relevant input.
  • Arrange secure shipments of wet-ink documents.

Key Skills:

  • Capability to work on multiple studies simultaneously.
  • Very good self-organization, time management skills, independent and structured way of working.
  • Ability to work within a team in a matrix organization.
  • Strong problem-solving skills.

Requirements:

  • Bachelor degree or equivalent, preferably in life science, clinical re- search, or related discipline.
  • Comprehensive practical knowledge of TMF processes, related standards (e.g. DIA Reference Model) and its quality control.
  • In-depth understanding of ICH-GCP quality standards and other relevant regulations
  • A minimum of 5 years clinical trial experience in the pharmaceutical industry or university hospital.
  • A minimum of 3 years' experience with the eTMF.
  • IT literacy, proficiency with Microsoft Office applications as well as practical experience with the electronic Trial Master File.
  • Fluent knowledge of spoken and written English.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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