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Submissions & Contract Coordinator (Study Start up)

Employer
Boehringer Ingelheim
Location
Bracknell, UK
Salary
Competitive
Closing date
4 Nov 2020

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Sector
Healthcare
Contract Type
Permanent
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OUR COMPANY

At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.

THE POSITION

This is an exciting opportunity to join our Clinical Operations team as a Submissions and Contracts Co-ordinator. Under the direction of the Submissions and Contracts Lead, you will coordinate and facilitate the country (specifically ethical and national study wide governance review) and site level set-up activities for Clinical Trials within the UK and Ireland on behalf of the Clinical Trial Manager (CTM), to minimise time to initiation.

You will also be responsible for coordinating and facilitating country and site level amendments to the original submission along with any associated contracting activities for ongoing studies on behalf of the CTM as well as supporting the feasibility process by initiating external research network and site contact during the initial country feasibility request.

Tasks & responsibilities
  • Performs set-up activities (to obtain national & local site approvals) in conjunction with the CTM, to ensure the smooth progress of trial set-up.
  • Responsible for the budget negotiation activities and execution of clinical trial agreements with sites.
  • Co-ordinate submission and approval of trial amendments (including contract amendments) to relevant authorities and institutions in conjunction with the CTM.
  • Maintain knowledge of and provide specialist advice, support and guidance to the Clinical Operations department concerning external systems, processes and requirements for national & local (ethical/site) approvals in both the UK and Ireland, in order to improve department knowledge and facilitate the consistent and timely set up of trials.
  • Performs feasibility (-country & site level) activities; coordination of external research network feasibility and liaising with sites to ensure adequate confidentiality clauses are in place. Also utilise previous site experience to proactively identify potential issues to enable informed site selection decisions to be made by the CTM.
  • Maintaining internal systems for tracking of assessment of Fair Market Value and retaining contracts and binding documents.

Requirements
  • At least 2 years of recent experience in Ethics Submission and Trial Site Contract activities for the UK and Ireland
  • Excellent communication skills
  • Ability to build strong relationships
  • Computer literate and proficient in Excel
  • Ability to manage multiple time bound tasks
WHY BOEHRINGER INGELHEIM?
With us, you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, numerous benefits towards your wellness & financial health and work-life balance. Plus, best-in-class cafeterias and coffee bars to keep you energized and healthy and other various benefits and rewards. To learn more about what benefits could be waiting for you, please visit our career area.
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