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Job Details

Trial Master File Lead - All EU Locations Considered

Company: INC Research
Location: All EU Locations
Reference: 17002712
Closing Date: 11 Sep 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life.

Requirements:

You’ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most.  In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA. 


We are currently looking to strengthen our Document Control team in Europe and are seeking a Trial Master File Lead (TMF Lead) to join our team and this position can be based in any of our EU locations and we can also consider a home working role for experienced candidates.

A brief summary of duties:
• Attends Trusted Process meetings such as Kick-Off, Quick Start Camps, Jump Start Camps, Quality Finish Camps, etc. as TMF Subject Matter Expert (SME) and successfully communicates and presents TMF status updates and seeks relevant information to drive the execution/delivery of the TMF.
• Leads the TMF set-up and structure, configures completeness reports and sponsor/project specific completeness reports, and develops the list of expected documents and the gap analysis.
• Collaborates with the Project Lead (PL) and Functional Leads (FL)
• Attends internal project team and sponsor teleconferences and face-to-face meetings as TMF SME as applicable to the project/program.
• Designs and/or delivers study specific TMF training
• Generates and provides Completeness Reports and inspection readiness metrics to the Project Team.
• Participates in audits/inspections and prepares for audits to ensure audit-readiness for the TMF.

 

Qualifications
 

To succeed in this role you will need the following skills/experience:


• BA/BS in the life sciences, business administration, or related discipline; or equivalent combination of education and experience.
• Moderate experience in a Contract Research Organization or related field.
• Experience with leading/co-leading studies from award into maintenance on a Global scale.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.
• Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills.
• Ability to perform several tasks simultaneously to meet deadlines.

 

What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.

Apply for this job: Trial Master File Lead - All EU Locations Considered

Contact Information:

Address:  INC Research Europe
Királyhágó tér 8-9, 2th floor, 1126 Budapest, Hungary
1126
Hungary
Tel:  +36 1 489 48 56
Website:  Visit Our Web Site

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