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Job Details

TMF Project Leader

Company: Phlexglobal
Location: Chesham, Bucks, HP5 2FW
Reference: PXGUK506
Closing Date: 17 Dec 17
Type: Full Time
Salary (£): Competitive
Benefits: Competitive

Job Summary:

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 interesting opportunity?


The opportunity:

Do you have experience of trial master file documentation and are looking for your next position? We have an opening within our TMF readiness department for an individual to provide leadership to a team of internal document experts in order to deliver TMF projects to the global clinical research industry.

The role:

You will be responsible for ensuring that the operational aspects of all client projects are delivered to the highest standard by appropriately qualified and trained resource.  You will actively work with the Head of TMF Readiness and governance team to drive and develop the department as a profitable operating unit within the business.

A full job description will be provided ahead of interviews but in brief, your role will include:

  • Planning, co-ordination, review and update of all TMF Readiness project related activities for assigned projects
  • Creation, review and update of process related documentation for the assigned projects
  • Ensuring projects are adequately resourced, work is allocated, tracked and quality checked
  • Tracking of KPIs (run rates, forecasting and other metrics) for projects to ensure that all tasks are completed to agreed timelines, quality and within budget
  • Conduct project team meetings
  • Provide regular updates/reports on work and progress to client, Client Project Manager and Head of TMF Readiness
  • Train, coach and mentor designated Readiness team members
  • Provide input for continuous improvement to TMF Readiness/Phlexglobal processes, including feedback from Project Lessons Learnt
  • Working in conjunction with Head of TMF Readiness on training and personal development plans for assigned team members (including ongoing training, review and assessment of Core Competencies and promotion)
  • Work with Business Development and Contracts to update contracts and work schedules as required

We are looking for individuals who:

  • Have a complete understanding of the clinical development process including knowledge of relevant and appropriate guidelines and regulations both nationally and internationally
  • Possess strong Project Coordination Skills from project start-up to closure.
  • Have proven training, coaching and mentoring ability
  • Can anticipate & manage client expectations
  • Possess problem solving and decision making skills
  • Have proven organisational and communication skills
  • Have a flexible, proactive, diligent and self-motivated approach to work

The ideal candidate will:

  • Be an effective communicator at all levels
  • Demonstrate strong interpersonal skills
  • Have Intermediate/Advanced Microsoft Word, Excel, PowerPoint and Outlook 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 PXGUK506, 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).

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.

Apply for this job: TMF Project Leader

Contact Information:

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

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