Roche

Study Start Up Specialist - 12 month Fixed Term Contract

Company
Roche
Location
Welwyn
Salary
Competitive
Posted
08 Jan 2021
Closes
22 Jan 2021
Ref
202101-100069
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Study Start-up Specialist - 12 month Fixed Term Contract

This is your chance to inspire and excel.  You will work with some exceptional people in a high-performing, collaborative culture, providing leadership and local strategic planning and organisation to ensure the effective and efficient start-up of studies in the UK.

Reporting to the Study Start-up Manager and in partnership with the Country Study Manager, you will be accountable for the quality and timeliness of site activation in assigned studies, demonstrating adherence to the appropriate standards, including ICH/GCP/GPP, Roche SOPs, local operating guidelines and local requirements, as applicable. 

You will also be accountable, in ongoing studies, for the maintenance of approvals critical to support the timely implementation of important study protocol and contract amendments. 

Your career to date will impress us…. Working as part of a cross-functional team, you will ideally have experience of clinical research and demonstrate a solid understanding of the associated UK regulatory environment and ICH GCP.  You will need a proactive approach and the ability to quickly grasp new concepts and processes, as well as the skills to understand and interpret complex clinical research protocols and to effectively communicate with others about these.   Experience of the following aspects of UK study start-up is highly desirable: 
  • Preparation of submissions through the Integrated Research Application System (IRAS) and to the Health Research Authority (HRA). 
  • Production of local Patient Information Sheets and other study specific documentation, for varied and multiple therapy areas and patient populations
  • Preparation and negotiation of study budgets and site specific contracts
  • Preparation of protocol and contract amendments
  • Understanding and oversight of UK regulatory requirements for safety reporting in clinical trials


You must be able to communicate clearly and accurately in both written and spoken English and have a demonstrated ability to interact with different professional levels of the research community and have a robust understanding of the UK clinical research environment.

Self-motivated and achievement driven, you will have substantial experience influencing and negotiating at all levels to achieve timely and efficient outcomes plus a demonstrated ability to prioritise and manage multiple tasks.  You must also possess strong computer skills, including the usage of MS Office software, web-based systems and databases.

The next challenge awaits…  here is your chance to use your operational expertise and your passion to be part of a committed team doing now, what patients need next.

We'll commit to your success...Alongside a competitive salary, your benefits will be comprehensive and our spectacular premises offer a productive environment with lots for you to enjoy. We'll provide all the support you need to further your career here in ways you might have never considered. Best of all you're going to work with some of the most inspiring and friendliest people you could hope to meet.

Begin something extraordinary and apply today!

Good luck with your application.

Roche is an equal opportunity employer.
Research & Development, Research & Development > Clinical Development