29 August 2017

 

IEC-Core Lab is currently seeking for a “Clinical Study Coordinator” able to manage all clinical studies being conducted at IEC.

As a core central lab, IEC centralizes image reading and analysis of multiple medical images using different radiological equipment. 

 

We are currently looking for a Clinical Study Coordinator

 

Key responsibilities:

  • Management and oversight of all aspects of IEC-Core Lab clinical studies in accordance with internal SOPs, ICH, GCP, relevant guidelines and all applicable laws and regulations.
  • Oversight of all aspects of the studies to ensure agreed study deliverables are met to the appropriate quality.
  • Manage all correspondence with the Sponsors, CROs and sites in regard to all studies being conducted at IEC.
  • Support selection and oversight of vendors (ie. Platforms, PACS, etc)
  • Support the team in the selection of suitable national sites to be part of IEC network
  • Set up and management of Clinical Site Agreements
  • Preparation of study budgets and discuss with the sponsors
  • Thorough documentation of study team activities, decisions, actions and risk assessments.
  • Active management of IEC team and supervise their daily activities
  • Ensure ‘inspection readiness’ of documentation at all times.
  • Develop and maintain relations with all stakeholders
  • Manage and supervise all Data Management activities being conducted at IEC

 

Essential Knowledge, experience and skills:

 

  • Candidates applying for this position will have a life science degree or similar, in addition to having experience at some level of global multi-center trials including oncology trials, preferred in using radiological endpoints.
  • At least three years working on a CRO or Pharma industry is mandatory (ie. CRA, LCRA, DM, PM).
  • You will be a highly motivated and dynamic project management professional with a strong commercial knowledge of the pharmaceutical industry, a positive attitude and ambition to make things happen.
  • You will need to be a natural leader with excellent communication skills able to work on a wide range of different activities
  • You must be able to set goals and achieve them by motivating your team and building strong relationships with a diverse range of both internal and external customers.
  • Oral and written fluency in Spanish and English
  • Previous experience with managing clinical trials
  • Previous experience in oncology and radiology
  • Previous experience in Data Management
  • Fluency with Microsoft office programs including
  • Ability to transcribe meeting minutes and document key action items
  • Comprehensive knowledge of GCP as it applies to clinical trial conduct
  • Comprehensive understanding of the regulatory aspects of study product management

 

If you are interested to join our team please, send you CV to the following email address:

 

4clinicaltrials@4clinicaltrials.es

 

We would like our candidate to join our team in October-November 2017.