Clinical Trials Applications Submissions Coordinator

  • Salary: £28.53 - £36.97 per hour
  • REF Number: 00047083
  • Consultant: Natasha Young
  • Contact: 01246 457739
  • Date Published: 29.11.2019
  • Sector: Non-Specific
  • Location:
  • Discipline: Regulatory Affairs

CK Group is recruiting for a Clinical Trials Applications Submissions Coordinator to join a company in the healthcare industry at their site based in Stockley Park on a contract basis for 6 months and has an hourly rate of £28.53 as a PAYE contractor or £36.97 as a Ltd/Umbrella contractor.

The Company:

As a global healthcare company, our client takes on some of the world's biggest healthcare challenges. By delivering a sustainable business, they provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. They have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. They are committed to widening access to their products, so more people can benefit, no matter where they live in the world or what they can afford to pay.

The Location:

Stockley Park was the UKs first and most successful business park. Situated close to Heathrow Airport in West London, it is home to roles within clinical safety, clinical data, conversion leads, programming, regulatory and more. It's a location that combines excellent transport links with the M4 and M25 motorways and Heathrow Airport a few minutes away. A choice of railway and tube stations, extensive bus networks plus ample parking provides a coordinated transport hub to connect to the Park.

The Role:

This role works with the Clinical Study Support Team Manager to ensure that appropriate content for specific submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with internal processes and policies as they apply to the role.

Key Responsibilities:

  • Responsible for development & refinement of the CTA lifecycle strategy and implementation of submissions.
  • Coordination of CTA lifecycle submissions to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with internal policy and procedures.
  • Accountable to the Clinical Study Support Team Manager for overall work plans.
  • Accountability for agreed tasks and projects.
  • Ensure independent communication, with a range of internal staff, in support achievement of the assigned goals.
  • Ensure compliance with internal CTA and maintenance process through timely action and completion of records in internal systems.
  • Ensure quality of own work to agreed timeframes, including compliance with internal systems and record keeping.

Your Background:

  • To succeed in this role you will have a broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives as well as Clinical Trial Directive and CTA submission requirements for multiple countries/submission types.
  • You will have excellent communication skills, attention to detail and a commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
  • A good understanding of Clinical Trial Directive and CTA submission requirements for multiple countries/submission types.
  • Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.

For more information or to apply for this position, please contact Natasha Young on 01246 457739 or email pharmacontracts@ckagroup.co.uk. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group 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 47083 in all correspondence.

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