Clinical Operations Manager
Paid. Full time or part time. Remote.
The mission we’re on:
Detect Alzheimer’s disease 20 years early, through speech-based algorithms
Alzheimer’s disease and other dementias will affect 1 out 3 people, causing progressive loss of memory – which is what makes us who we are. No disease modifying treatment exists. Today we know that the disease progresses silently for decades before symptoms become obvious and diagnosis happens. This is a prime reason why treatments don’t work. We also know that very subtle symptomatic changes do exist in the silent stages – in episodic memory, executive function, and language production. With sophisticated enough technology, these changes can be detected in the way someone speaks.
Novoic is a clinical stage biotechnology company developing algorithms to detect neurological diseases such Alzheimer’s disease in their preclinical stages, by analysing audio-linguistic patterns of speech. Building on decades of research, the company is currently testing these algorithms in the clinic, to validate them as software-as-medical-device, and bring the first clinically viable speech-based algorithms to market. The company is venture capital funded, working with the Alzheimer’s Drug Discovery Foundation and Gates Ventures to develop a global standard for speech biomarkers, and has been backed by the UK NHS’ AI organisation – as the world’s only speech company–to test out its algorithms in more than five common neurological and psychiatric indications.
Founded by Oxford and Cambridge researchers, our team is a reflection of the pioneering nature of our work. Physicians, clinicians, and neuroscientists work side-by-side with machine learning researchers, software engineers, and developers. All united by a mission to help patients and their families through early, non-invasive diagnosis.
Why we need you now
The past year, we have completed a number of proof of concept studies and set up our first clinical studies to investigate and develop the technology further. The next stage for Novoic is about the larger and wider scale clinical validation of the biomarkers we are developing. As part of this we are going to run a number of clinical trials, across the US and the UK. We’re building our internal clinical team to start up and run these studies efficiently and reliably. Being the company’s most experienced, but still hands on expert in clinical operations, you will be one of the core, founding members of this clinical team, helping us launch and manage our studies much better then we could without you.
What will you actually do
- You will become an expert on the studies we are running and be Novoic’s key point of contact for our Investigator Sites participating in Novoic’s US-based trials. You’ll need to manage these relationships, answer questions from Site staff, and make sure that everything is going smoothly.
- You will help with or perform (mostly virtually) site training and monitoring visits with US sites. You will be responsible for ensuring that trials run according to GCP, HiPAA, GDPR and all other applicable standards.
- You will help us write and edit protocols, patient information sheets, informed consent forms, SOPs and other key documents regarding our trials.
- You will be responsible to secure and maintain IRB/ethical approvals for our studies in the US.
- You will have various tasks regarding trial start-up, setting up data capture, data management and reporting processes, reviewing clinical data and investigator site files for completeness, clarity and conflicts.
Who are you
- You have 2-6 years of experience in clinical operations. You could have worked in a clinical research site, institution; a small CRO or a biotechnology/medical device company.
- You are experienced in the organising and management of clinical trials. You have been involved in complex multi-site clinical studies before in some capacity, and know the processes that need to be in place at a site, and other levels of a trial. Having run multi-site studies before as part of a CRO/sponsor organisation is not a requirement.
- You have written or edited patient information sheets, informed consent forms before, and know what it takes to run a study compliant with GCP, HIPAA, and other applicable regulations. Your experience is mostly specific to the US.
- You pride yourself on how well-organised you are. Nothing slips through the cracks!You’re able to work in a fast-paced environment without a lot of corporate/organisational structure.
- You are self-driven, take ownership of your tasks and projects, and probably prefer working without constant supervision and close instructions. You also love collaboration, and don’t mind mentoring and sharing your knowledge with less experienced team members so you can work together better.
- Competitive salary and option arrangement. 28 days of paid holiday.
- Flexible working arrangements, including remote work policy.
- A deep sense of meaning, having a significant role in changing the way brain diseases are diagnosed, improving the lives of millions.
- High degree of responsibility and the opportunity to grow into a senior role as the company scales.
- Personal development plan and half a day per week to work on your own projects.
Our office is in London, United Kingdom. While we would try to arrange occasions to meet with you in person, this would primarily be a work-from-home role. We expect most applicants to apply from the United States, but you can apply and live anywhere in the world.
We are looking for someone to join us full-time, but part-time arrangements are also possible. The starting date is ASAP.
Novoic is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.