Associate Clinical Operations Manager
AviadoBio, United Kingdom
Job Description
Job Description
Associate Manager, Clinical Operations
The Company:
At AviadoBio, our mission is to transform the lives of people living with neurodegenerative disorders by developing and delivering transformative gene therapies for diseases such as frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS). The company’s technology is based on the pioneering research of Professor Chris Shaw, Professor of Neurology and Neurogenetics, Kings College London, with the support of UK Dementia Research Institute and backing from leading life science investors.
We are rapidly building an experienced and talented team to deliver on our mission to make a meaningful impact to people living with neurodegenerative disease. It’s a great opportunity to join a truly innovative and exciting gene therapy company at an early stage, where your work will be impactful and you will benefit from a collaborative, inclusive, open and friendly working environment, which promotes professional development.
The Role:
We are seeking an Associate Clinical Operations Manager with a good background in Clinical Operations and/or clinical research experience in general, who is driven by the desire to develop potentially transformative treatments for patients with neurodegenerative diseases. This position offers the opportunity for growth and development in a fast-paced, dynamic biotech environment, and would suit candidates with e.g. some experience, either as a CRA or other in-house role, such as a CTA.
Reporting to the Senior Director of Clinical Operations, you will support the clinical operations team in the planning and management of phase I/II and phase III clinical trials including; key project deliverables, timelines, quality, budget, resources and oversight of Service Providers (CROs and other specialist vendors). This role will provide a rare opportunity to gain experience in early phase (first-in-human) gene therapy studies, whilst also contributing to strategic planning for later phase studies. As the company will be expanding significantly over the coming few years, there will be good opportunities for career development. You will have exposure to all aspects of clinical operations activities within the company.
Responsibilities:
- Contributing to the operational delivery of outsourced Phase I/II and Phase III clinical studies, managing study deliverables as well as CRO/vendor relationships and performance
- Ensuring adherence to internal and external (CRO) SOPs, plus ICH-GCP requirements
- Planning, management, tracking and reporting of various CRO-related KPIs, such as; site initiations, patient recruitment, data entry, query resolution
- Identification and resolution of operational issues, risk mitigation and internal communication of study status/ progress
- Operational responsibility for oversight of the CROs/vendors, including performance, quality and budgets, throughout the life of assigned clinical studies
- Operational input into the implementation and maintenance of high quality, key study-related documents and procedures, delivered at the required time points within the study life cycle
- Attending visits to sites throughout the EU (and potentially US), to provide Sponsor input into site set up and maintenance, and to foster good Sponsor-site relationships.
Requirements
- BSc or equivalent university degree in Life Sciences or Healthcare (MSc/PhD is a plus)
- Previous experience in clinical operations, either as a CRA or other in-house role, such as a CTA
- Demonstrable knowledge of/ experience with general clinical operations activities of Phase I-III clinical studies (early phase experience being a plus), from study start up, through maintenance phase and on to close out
- Willingness to travel both within the EU (e.g. 1-2 trips per month) and occasionally US (e.g. 1 trip per quarter)
- Good working knowledge of ICH-GCP, experience with working to internal SOPs
- Willingness be coached/ mentored by senior members of the Clinical Operations team, as an essential element of your career development
- Experience in working with Service Providers (CROs, Specialist Lab Vendors)
- Previous experience working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS).
Benefits
As well as the exciting nature of the role itself, you can expect to benefit from:
- Competitive Salary
- Annual Bonus
- Exciting Equity Plan
- Pension Scheme
- Fantastic Private Healthcare Coverage
- Life Insurance
- Career Development Opportunities
For more information, please don't hesitate to reach out! We'd love to hear fr