Clinical Endpoint Specialist (Project Manager)

Location
London
Salary
Dependent on experience
Posted
21 Jan 2021
Closes
20 Feb 2021
Ref
J5634310
Contact
Eve Hegarty
Contract Type
Permanent
Hours
Full Time
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.

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