Job Title: Clinical Operations Associate

Location: Wales

If you’re an experienced clinical trials administrator and you’d like to hear about an opportunity with a genuinely exciting biotech company it would be great to hear from you.

Our client is a leading biotech company with an exciting pipeline focused on developing clinically challenging products in oncology and immune related rare diseases, using our innovative drug delivery technologies. They are at the forefront of developing new nano and micro drug delivery technologies to generate medicines that address unmet medical needs.

As part of the company’s transition to a clinical phase business they are recruiting for a clinical operations associate

Job Overview

Based in Cardiff, this is an opportunity for an experienced clinical trials administrator to establish and manage a clinical trials document system from scratch. The candidate will work with internal and external partners to develop and manage a trial master file (TMF) system, manage the flow and appropriate actioning of clinical trial documentation between investigators, CROs, and medical/regulatory affairs personnel, and provide general clinical operations support to CROs and Investigators for planned and on-going clinical trials.

Key Responsibilities

  • Ensure all clinical trial activities undertaken comply with SOPs, ICH/GCP, EU Directive, statutory instruments and all local regulatory requirements
  • Prepare study documentation for clinical study files according to company SOPs and regulatory guidelines
  • Support preparation of the study TMF plan with the assigned Clinical Project Manager
  • Set-up of Study, Country and Investigator TMF in accordance with the latest DIA reference model
  • Support set-up of Pharmacy, Laboratory and Radiological Investigator files, as necessary
  • Conduct full QC of study documentation prior to filing in the TMF
  • Maintain the Study Trial Master file:
    • Ensure all documentation meets legibility standards for accuracy and authenticity
    • Ensure all documents are coded to DIA sections accordingly
    • Support regular QC and gap analysis of the TMF as directed by study CPM
  • Prepare and distribute information to sites as required
  • Manage and support preparation of confidentiality agreements (CDAs) for sites and vendors; track, ship and log accordingly
  • Manage and support document control tracker of essential study documents as per SOP, for example Protocol, IB, ICF, Study Approvals
  • Manage and support the archiving of TMFs

Requirements

  • Solid experience and a proven track record of efficient and effective management of TMFs and clinical trial documentation systems
  • Solid experience working in a clinical operations team within a clinical CRO or Pharmaceutical R&D environment
  • A thorough knowledge of operational support requirements for clinical trials
  • A thorough knowledge of GCP
  • A highly organised nature
  • The ability to manage and collate activities and information from multiple simultaneous work streams

Our client offers an opportunity to join an incredibly exciting, high tech business that is expecting to make a huge impact on the lives of people living with cancer and auto immune diseases. The role will offer autonomy and scope for technical and career progression and you’ll be a recognised and valued member of the leadership team.

To Apply

Sent a word formatted CV to jack.relfe@bluepelican.com and I will contact you.

Jack Relfe

Blue Pelican

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How to apply

If this position is of interest please send us your CV here, or you can call Jack Relfe direct on 01892 507 134 to discuss this and other vacancies that may suit.

Jack Relfe

Associate Consultant - Pharma
Email: jack.relfe@bluepelican.com
Prior to joining Blue Pelican I worked within insurance, where I felt like I was not utilising my skills and it was just...