Local Document Specialist

  • Salary: Competitive
  • REF Number: 00030405
  • Consultant: Oliver Care
  • Contact: 01438 743047
  • Date Published: 18.07.2014
  • Closed Date: 24.08.2015
  • Sector: Non-Specific
  • Location: South East
  • Discipline: Regulatory Affairs

Oliver Care is recruiting for a Local Document Specialist to join a company in the pharmaceutical industry at their site based in Berkshire on a contract basis.

The main purpose of the role will be to:

  • Process CTMF documents in accordance with relevant SOPs, local working instructions and ICH-GCP standards to include production of submission sheets, tracking. scanning, importing and filing of electronic and hard copy documents. Meet timelines and perform post-scanning quality reviews.
  • Perform CTMF checks at agreed time points e.g. post study initiation and close out in accordance with company guidelines Have periodic meeting with the TCM/CML to obtain an overview of studies and feedback on the health/quality of the CTMF and escalate quality issues.
  • Complete the technical elements of Clinical Trial Report appendices compilation and support users in the production of Investigators Brochure, Clinical Trial Protocol and CTRs within the companies EDMS. Establish good working relationships with Clinical Teams.

Further responsibilities will include:

  • Overseeing recall of clinical trial documents from deep archive and liaising with CMs to obtain permission to deep archive CTMFs and to obtain authorisation to destroy documentation once the retention period is exceeded.
  • Attending logistical set-up meetings as required and representing EDMS users at key user meetings maintaining knowledge of the system in order to support users effectively.
  • Coordinating the provision of documents required for internal audits and regulatory authority inspections and provide full support to any preparatory activities for inspections. Act as a mentor to other CDSC colleagues and provide training, advice and support where required.In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
  • Educated to degree level or above in a relevant field with substantial related experience within pharma or CRO.
  • Understanding of clinical trial, essential document archiving requirements and knowledge of ICH-GCP
  • Computer literacy in Excel, Access and Word.

This is an excellent opportunity to join one of the top 20 pharmaceutical companies in the world with a focus on innovative research and development.

For more information or to apply for this position, please contact Oliver Care on 01438 743047 or email ocare@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.

CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL30405 in all correspondence.

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