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Job Details

Document Management Specialist (experienced Trial Master File Administration)

Company: Phlexglobal
Location: Chesham, Bucks, HP5 2FW
Reference: PXGUK359
Closing Date: 14 Nov 16
Type: Full Time
Salary (£): Competitive
Benefits: Competitive

Job Summary:

A great opportunity for a senior level TMF (Trial Master File) team lead looking for that next step!


The opportunity:

Are you an expert in Trial Master Files looking for a fresh challenge or have a number of years TMF experience and looking for that next step in your career?    We have a great opportunity for a senior level TMF (Trial Master File) team lead to work with project managers, clients and our internal document experts for TMF Inspection readiness.

The role:

You will provide TMF Subject Matter Expertise within the department ensuring that projects are delivered to the highest level of quality, on time and within budget.
A full job description will be provided ahead of interviews but in brief, your role will include:

• Lead projects for Pre Audit/Inspection review of TMF documentation
• Day to day project and team oversight including process, quality and metrics
• Training, Mentoring and coaching of team members

We are looking for individuals who have:

Significant current experience as a CTA or similar
Have excellent knowledge of ICH GCP
Have excellent working knowledge of clinical study documentation
Have advanced skills in Microsoft Office products (e.g. Outlook, Excel, Word, databases)
Coach / Mentor / Supervisory Experience
Excellent attention to detail
Excellent verbal and written communication skills

We understand the need to balance work and life commitments and can sometimes accommodate more flexible start and finish times within the core hours of the role. If this is of particular interest to you, please discuss this with us before submitting your application.

To Apply:

Please apply quoting vacancy reference number PXGUK359, stating your minimum salary expectations and notice period.

We look forward to hearing from you!

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.

The Company

Phlexglobal is a specialist provider of technology-enabled, Trial Master File (TMF & eTMF) document management solutions and other support services to the global clinical research market. We offer a unique combination of clinical trial knowledge, document management skills, regulatory understanding and technical expertise to deliver a range of flexible, targeted solutions to meet business needs.


eTMF / TMF/ Trial Master File / Clinical Study / Clinical Manager / Clinical Trials Assistant  / CTA / CRO Project Coordinator / CRO Project Manager / Senior Clinical Project Coordinator / Line Manager / GCP Project Manager / Clinical Project Manager / Clinical Process Manager / Perm process manager / Clinical / clinical training / Phlexglobal / Clinical Trials / Study Manager / Clinical Study Manager / document management / clinical documents

Apply for this job: Document Management Specialist (experienced Trial Master File Administration)

Contact Information:

Address:  Head Office
Mandeville House
62 The Broadway
Tel:  +44 (0)1494 720420
Website:  Visit Our Web Site

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