Product Trials Performance Manager
We have created Genedrive, a potentially disruptive and low cost Point of Care real-time PCR system that can serve as the basis for rapid detection, quantification, or drug resistance testing of infectious diseases and pathogens, such as TB, Hepatitis, or HIV. With an opportunity to reach millions of people with poor access to existing diagnostic technology, Genedrive has the ability to change lives.
As we grow our Manchester based team, we are looking for a Product Trials Performance Manager to report to our Chief Commercial Officer.Our portfolio of medical device products means that we have trials based in the UK with the NHS and across the world in low-to middle income countries where our products will help in the fight against global infectious diseases. It’s important that you have strong interpersonal skills as you will be dealing with key opinion leaders. There’s a lot to do but it’s exciting, and equally important, it’s meaningful.
As our Product Trials Performance Manager, you will report to the Chief Commercial Officer and your main day to day responsibilities will involve the following:
·You will provide oversight and management of individual study sites for both clinical trial and regulatory requirements, as well as commercial performance studies to aid the commercial launch of Genedrive;
·You will bethe Clinical Performance Study coordinator for all studies, undertaking all required activities to ensure a successful outcome including study start up, initiation, monitoring, and tracking of trial documentation;
·Writingstudy protocols using best practice to ensure a smooth process;
·As part of the study process, you willmonitor and review all data coming from the study site and rectify any problems that may occur;
·Prepareand/or review our marketing materials to ensuring accuracy on technical points and suggest source references and improvements as required;
·Work with the Marketing team, to identify, visit and work with key opinion leaders ;
·Provide training to our distribution partners to ensure that they are competent in working and demonstrating the Genedrive instrument;
·Act as the Genedrive 'subject matter expert’ within trial sites by providing technical training as required for the successful completion of the study and deliver any necessary refresher training;
·Collaborate with study sites to produce publications/ papers/ abstract.
Knowledge Skills & Abilitie Required
You will be have the following skills and abilities :
·Previous CRA experience initiating and monitoring industry sponsored and investigator led trials ;
·Experience of interacting commercially and scientifically with KOLs;
·Strong analytical skills with ability to research, analyse and interpret study data;
·Able to generally understand, interpret, and explain protocol requirements to others;
·Have the ability and enthusiasm to work on challenging projects which may not always be clearly defined or structured, and have the ability to self-direct and define what the project should look like, ensuring alignment to the business objectives and the market and customer needs;
·Demonstrate a high degree of professionalism at work combined with strong ownership and accountability of work packages, deliverables, and due dates;
·Able to work independently as well as team oriented with strong communication skills environment;
·Ability to travel internationally, occasionally >1 week at a time;
·Excellent written and oral communication skills;
·Excellent skills with Microsoft Word, Excel and PowerPoint is required as well as comfort with basic statistical analyses.
·You MUST have the legal right to work in the UK or EU
Desired Experience & Qualifications:
·Minimum of a University degree in Life Sciences or equivalent. APh.D. preferred or equivalent experience is desirable ;
·Experience with medical devices preferred, although we will consider similar experience within the pharma sector ;
·Biomedical Scientist or equivalent experience preferably working in infectious diseases;
Where will I be working?
·You will be based out of our offices in central Manchester within the Core Technology Centre of the University of Manchester Innovation Centre (UMIC) at 48 Grafton Street-off Oxford Road;
·You will also be required to travel to work with KOL’s and with our studies across the globe - including Africa & Asia for up to 25% of your time may be spent travelling and working abroad.
Hours of Work
You will be required to work 37.5 hours per week.
We provide Private Healthcare, Death in Service Benefit, Group Income Protection, Share -Option Scheme, 25 days’ holiday plus 8 statutory bank holidays) per year, discretionary bonus and a Group Personal Pension scheme.
How to apply
If you would like to apply for the role of Product Trials Performance Manager, please send in your CV with a covering letter.
Please focus on telling us how your skills and experience match the type of person we are looking for and why you believe you would be an ideal candidate for the role of Product Trials Performance Manager.
Closing Date: -31st July 2019
- Medical Devices
- Regulatory Requirements
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