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Raise your Standard - Join the TMF Authority!

Trial Master File Study Owner

Posted by Phlexglobal Careers | May 15, 2019 8:50:09 PM

Love TMFs but tired of filing? Do you have what it takes to be a TMF Subject Matter expert? We have this exciting role for you if you do!

The role:

Working for Phlexglobal you will be working in collaboration with one of Phlex’s top 10 blue-chip clients as a TMF Expert. The role can be office based in Chesham, Buckinghamshire or home based within the UK. This position is a permanent position. 

You will be an ambassador of the TMF. Working with global client’s or CRO study teams, you will possess strong communication skills with the ability to lead and coach the study teams in good TMF practices ensuring the TMFs are Inspection ready at all times. As part of your role, you will setup a TMF structure to facilitate study teams to file and have oversight of TMF metrics. You will be a core team member attending regular study team meetings, managing the compliance and health of the TMF by advising the Project Managers and Study team of compliance issues and following up until resolution.

 

We are looking for individuals who have:

  • Previous direct TMF working experience.
  • Extensive Clinical Documentation Management and industry experience, with a thorough understanding of clinical trial project lifecycle and document management.
  • Experience with Electronic document management systems and other Clinical Databases. 
  • Experience supporting regulatory submissions and inspections.
  • Intermediate MS Word, Excel, PowerPoint and Outlook. Experience of using Skype and other web based telephone conference services
  • Excellent negotiation and conflict resolution skills. Communicating well with colleagues and associates both inside and outside the organization. 
  • Able to work independently, be proactive, diligent and self-motivated. 
  • Have a flexible approach (sometimes outside of normal UK working hours) in order to be able to support teams worldwide. 
  • Extensive knowledge of vendor processes.
  • A sound knowledge of working across international boundaries and cultures.
  • Flexibility to travel national/internationally (as and when required.)

 

The ideal candidate will have:

  • A Bachelor’s degree
  • Previous remote working experience

 

Why Work for Phlexglobal?

We offer challenging careers, projects, great benefits and a comprehensive and competitive rewards package, including great training and personalised career development opportunities.

Our benefits typically include a competitive base salary, generous annual leave and flexible working arrangements. We also provide pension, private medical insurance and life assurance, as well as access to many other benefits including our exclusive retail and gym membership discounts scheme (subject to eligibility). We constantly review our rewards package to ensure you have the best range of benefits available.

Your career and personal development is important to us. We provide you with all the training you need to develop the knowledge and skills to be successful at work. We also provide personalised learning and development plans, access to our training and professional development programmes, and regular performance reviews to enable you to achieve your career development goals.

All our benefits are subject to the terms and conditions of your employment.

Job ID: PXGUK612

To Apply:

To apply please complete the below form and upload your resume or CV. We look forward to hearing from you!

Topics: United Kingdom

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