Study Start Up Regional Lead

We are currently looking for a Study Start Up Regional Lead to join a leading Global Pharmaceutical Company based in the Buckinghamshire area. As the Study Start Up Regional Lead you will be in charge of and oversee start-up activities and directly manage a team supporting you with Study Start up and Contract Management. You will oversee both Internal and External Study Start Up within your region of responsibility and report directly to the Director of Drug Development Operations.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Study Start Up Regional Lead will be varied however the key duties and responsibilities are as follows:

1. Advise and support teams in the development of the regional start up strategy, risk assessment, and contingency planning as well as partner with key stakeholders to support start up milestones and KPIs, with a focus on critical path activities.

2. You will collaborate with external vendors to deliver Study start up timelines and provide oversight of the Clinical Trial Agreement (CTA) process including the development and maintenance of the core contract templates supporting R&D trials.

3. You will coordinate Study Start up tracking and be responsible for process improvement activities to increase quality and efficiency while working to cut cost where appropriate.

4. Provide leadership, support and coaching to develop Study Start up and Contract Management teams and maintain operational oversight.

5. You are expected to become a subject matter expert within the region of responsibility and highly knowledgeable of best practise for Study Start Up and Contract Management activities.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Study Start Up Regional Lead we are looking to identify the following on your profile and past history:

1. Relevant degree in a Science or Health related discipline with significant Clinical experience with an emphasis on Study Start Up and / or Contract Management activities.

2. A proven understanding of Good Clinical Practise (GCP) regulations, ICH-GCP guidelines, PhRMA code as well as UK and European Clinical regulations.

3. A working knowledge and practical experience with Team Leadership and Project Management of Clinical Studies will benefit your application.

Key Words: Study Start Up | Contract Management | Clinical Trial | CTA | CRO | Good Clinical Practise | GCP | ICH-GCP | PhRMA | Drug Development | Pharmaceutical | Biopharmaceutical

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.