Clinical Affairs Scientist

* This is a 12-month fixed-term contract position, starting as soon as possible, (37.5 hours per week, Monday to Friday) *

Are you looking for the next step in your career at OGT?
Or perhaps you know someone who would be a great fit for our Company and would like to explore joining us?
If so, read on and find out more about our latest opportunity as a Clinical Affairs Scientist in our Cambridge based Regulatory, Medical and Quality Team.

Our Clinical Affairs Scientists are knowledgeable individuals who are passionate about ensuring that OGT’s products are safe, effective and fit for purpose, thus allowing them to be available globally and state of the art. You’ll work for Geetha Selvaraj, Medical Affairs Project Manager, and play an integral role on a wide range of tasks to ensure the smooth management and execution of clinical trials for a range of the OGT products. You’ll also have line management responsibilities for one direct report.

What we are looking for in you:
A background in a Science related subject, preferably to MSc or equivalent qualification
Experience providing operational insights into clinical/scientific trial design, including clinical/scientific protocols, amendments, informed consent forms, study guides and case report forms
An ability to use your scientific knowledge to problem solve and trouble shoot technical laboratory issues
Experience of working in a GLP environment with experience and knowledge in cell culture and cell enrichment protocols.
Exceptional attention to detail with very good organisational skills with the ability to manage your daily/weekly workload
Adaptability and high levels of motivation with the ability to work independently as well as part of a team
The ability to follow exact detailed processes carefully
Knowledge of cytogenetic processing methods and FISH analysis, desirable
Previous experience managing a small team (desirable but not essential)
 

What you’ll be doing for us:
Participate in the design and reporting of any necessary clinical trials directly or via Contract Research Organisations (CROs)
Set up and execute trial protocols and be accountable for their timely executions
Collating trial data using in-house or external specimens as required (haematological specimens)
Processing and accurately recording biological samples and cell lines
Laboratory activities such as biological sample and cell line culturing, cell enrichment and protocol set up and troubleshooting
Contribute to the analytical and practical workload within the MA team, using in-house or external specimens as required
Act as external study monitor, liaising and coordinating with external clinical sites to provide required clinical data
Responsible for the line management of our Clinical Affairs Analyst
This role involves contact with and expose to human tissue therefore seropositive immunisation against Hepatitis B is required at point of commencing work.

This role is suited to somebody who is keen to be lab based and travel for a maximum 20% of their working time to visit clinical labs internationally (US/EU).

Of course, there’s always some admin to do, this will include assisting with report writing and involvement with procedures and audits as a part of the Quality Management System. You’ll also play

an important role in the smooth and efficient functioning of the laboratory, including consumables, reagents, microscopes, equipment and software.

 In return you’ll receive:
Competitive salary
Pension Scheme (10% non-contributory)
Private Health Insurance
21 days holiday plus UK bank holidays
High Street Discount Scheme
 

If this has piqued your interest, then our Regulatory, Medical & Quality Team would love to hear from you.

To apply we’ll need your current CV & a one-page covering letter outlining your suitability for the role, salary expectations and notice period.

Please note that we will need to establish your right to work in the UK during the recruitment process.