Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

Vacancy: Ass. Director – TMF (Biogen Idec)

  This position is responsible for managing overall Trial Master File (TMF) operations including third party vendors and TMF systems. Act as a single-point-of-contact for all vendor inquiries and for all TMF vendor management activities (e.g. performance management, issue resolution, … Continue reading

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Vacancy: Head of Trial Master File (INC Research)

Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical … Continue reading

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Vacancy: Head of Clinical Documentation (GSK)

Requisition ID: WD31952 Position: Full time Open date: Jun 2, 2015 9:25:42 AM Functional area: Medical and Clinical Location: Uxbridge, Middlesex Upper Providence, Pennsylvania Required degrees: Bachelors Experience required: Not Indicated Relocation: Yes APPLY NOW Basic qualifications:  Bachelors Degree Preferred qualifications:  Masters … Continue reading

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Now is the Time for the Electronic Investigator Site File (eISF)

The latest issue of Applied Clinical Trials included an article with some interesting statistics regarding clinical trial sites (see ‘Characterizing the Real Cost of Site Regulatory Compliance’ by Kenneth A. Getz). The statistics quoted come from a survey conducted at the … Continue reading

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EMA Cancels Revision of Reflection Paper on Trial Master Files

On 1st February 2013 the European Medicines Agency (EMA) released for public consultation a draft reflection paper on GCP compliance, including management of trial master files. After a three month consultation period which ended on 30th April 2013, industry has … Continue reading

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Thoughts from the DIA EU Electronic Document Management Conference

[Also posted on LinkedIn Pulse] I have just attended the 15th Drug Information Association (DIA) European Electronic Document Management conference in Berlin. Here are a few thoughts and observations that came to mind as I sat through some of the … Continue reading

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How to Implement a Successful eTMF Project

If you are considering implementing an eTMF or perhaps you are already in the middle of such a project, there is still time to register on our 1-day eTMF workshop being held on Monday 1st December in Berlin, Germany. Technology solutions … Continue reading

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