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Clinical Endpoint Specialist (Project Manager)

Employer
Hyper Recruitment Solutions
Location
London
Salary
Dependent on experience
Closing date
20 Feb 2021

Job Details

We are currently looking for a Clinical Endpoint Specialist to join a growing biotechnology company based in the London area. This could be a fantastic opportunity for someone working as a Clinical Project Manager looking to apply their skills to something slightly different.

As the Clinical Endpoint Specialist you will contribute to the execution of gene therapy projects by working with clinical and regulatory teams to ensure novel endpoints and assessments are appropriately validated and can be scaled up for use in multiple sites.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Clinical Endpoint Specialist will be varied however the key duties and responsibilities are as follows:

1. Work closely with the clinical and regulatory teams to understand regulatory requirements for validating and implementing study endpoints. Working with property management companies to secure potential research facilities for the duration of projects
2. Ordering and arranging the shipping of supplies to sites positioned globally. Work closely with clinical sites to manage the set up and installation of assessment devices
Co-ordinate the manufacturing components required to up-scale assessment capability to multiple sites

3. Good understanding of procurement, RFI/RFP, vendor selection, contracts, management, set up and tracking of performance. Ensure assessment capability is in place to coincide with study start up. You will also be responsible for cost management.

4. Ensure activities are conducted in compliance with applicable regulations and Good Clinical Practice. Understand the technical requirements for the assessments, their mode of operation, and how that translates to clinical need.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Clinical Endpoint Specialist we are looking to identify the following on your profile and past history:

1. Relevant degree in a sciences, engineering, nursing or pharmacy related discipline. In addition, you must demonstrate prior experience working within clinical trials or the pharmaceutical sector.

2. Proven practical experience of the clinical trial process and drug development, including working with industry regulators eg. MHRA and FDA.

3. A working knowledge and practical experience with DIA Trial Master File Reference Model, is beneficial but not required.


Key Words: Clinical Trial, Pharmaceutical, Drug Development, MHRA, FDA, Project Manager.

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.

Company

Hyper Recruitment Solutions is a specialist and highly compliant recruitment consultancy dedicated to the Science and Technology sectors.

Hyper Recruitment Solutions (HRS), founded and run by Ricky Martin and in partnership with Lord Alan Sugar, has a wealth of recruitment expertise as well as compliance and commercial awareness. We offer a range of permanent, temporary and contract staff.

Our vision is to provide recruitment solutions which will assist in the improvement and quality of life for all. To do so, HRS will focus on the support of sectors whose primary focus is in making the world a better place. This could be working for a Pharmaceutical company who is developing new and existing therapeutics or an FMCG business who is making the latest consumer products in a sustainable and efficient way. We want to provide a service to those areas of actual need which will have an impact on us all.

We provide services across a broad range of industries including the following specialist sectors:

• Biotechnology
• Pharmaceutical
• Medical Device
• Clinical Research
• CMO / CRO
• Food / FMCG
• Engineering
• Science

With all jobseekers we are looking to form close relationships where we can offer you the most accurate and useful advice. We intend to not only find and present the most ideal career options to you, but we want to provide advice on the entire recruitment process. We are a business who listens and advises and as shown on our website we have a clear ‘candidate commitment’ to ensure your search is in the most professional and capable hands. Some of the key areas we focus on include:


• Quality Assurance (including Qualified Persons)
• Clinical Research (all phases and therapeutic fields)
• Bioinformatics
• Research & Development
• Consumer Insight and Sensory
• Lean and Continuous Improvement
• Engineering (all disciplines)
• Manufacturing, Scale up and Technology Transfer
• Packaging and Sustainability 
• Medical Affairs
• Sales and Business Development
• Information Systems & Technology
• Executive Appointments


HRS has been awarded membership to the REC (Recruitment and Employment Confederation) and APSCo (Association of Professional Staffing Companies). This is to assure all clients and candidates that our processes and practices comply with all relevant government and recruitment industry regulations.

Lord Sugar, Ricky Martin and everyone at HRS look forward to working with you. Please do not hesitate to visit our website www.hyperec.com or contact us via
Telephone: 02032 255 120
Email:info@hyperec.com


Or any of the social media routes below: 
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Company info
Website
Telephone
0203 910 2980
Location
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB

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