Company: Aerotek (Allegis Group) Ltd
Closing Date: 05 Dec 16
Salary (£): 20,000 - 30,000
Benefits: Excellent Benefits & Packages
My client who is a global market leading pharmaceutical company is looking for a motivated, driven and fast learning individual to join the team on a permanent basis. The successful candidate will have the opportunity to work on high priority studies and work collaboratively across functional areas and contribute to positive team relationships, both locally and globally.If the role is something that is of interest to you, please don't hesitate to apply below.
* Perform various TMF activities associated with TMF Management, including TMF setup, eTMF query resolution, eTMF user support and training. Assist with developing training materials and conducting TMF training for global eTMF users
* Perform the activities associated with quality control reviews of study TMFs to ensure adherence to SOPs and regulatory requirements and that the TMF is inspection ready. These activities include: preparing the Study QC Review Plan and conducting associated risk assessments; perform QC reviews; prepare QC Findings reports; assist with analyzing trends and preparing metrics; Provide feedback to project teams and /or management for the correction and resolution of document quality issues, TMF completeness and timely submission of documents to the TMF
* Functions include: Performing TMF set-up and maintenance; Archiving of TMFs; Assisting with the oversight of the eTMF vendor and business process; eTMF query resolution, eTMF user support and training; Performing quality control (QC) review of study TMFs to ensure they are of the highest quality and inspection ready, adhere to SOPs, and meet compliance specifications according to regulatory requirements and ICH guidelines.
* Education to B.Sc. level or equivalent, preferably in a scientific discipline
* Strong background (3+ years) in the pharmaceutical industry, preferably in regulatory operations or clinical development/operations
* Must have strong document management skills, including experience with review of regulatory documents, be detail oriented, organised, quality driven and able to work in a team environment under tight deadlines
* Must have strong knowledge of and be able to differentiate all key clinical trial essential documents (e.g., IBs, ICFs, CRFs, Protocols, regulatory approval documents).
* Must have good understanding of the clinical development process, including regulatory documents and regulatory requirements (including ICH and GCP guidelines)
* Knowledge/understanding of TMF requirements and technologies to support document collection and archiving; eTMF experience preferred
Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice http://www.allegisgroup.com/Privacy/Default.aspx). By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.
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