Clinical Research Project Manager: Help fight cancer with AI

About us

We are a fast-growth AI start-up seeking to solve one of the biggest problems in healthcare: early interception and treatment of lung disease, starting with the deadliest: lung cancer. Our vision is for every lung cancer patient to be treated at the earliest stage and cured.

As a company, we promise our team members:

• High impact and rewarding work
• Professional development opportunities: grow your knowledge of diagnostics and AI
• Opportunities to connect with serial entrepreneurs, world-leading AI experts as well as key opinion leading clinical experts around the world
• Competitive salary and benefits, including the possibility of share options
• Flexible working hours from the outset, including the opportunity to work remotely

Our initial product is the world’s first AI-powered clinical decision support software for early diagnosis of lung cancer, which enables every clinician, in every hospital, to manage their patients in the optimal way.

Optellum is an equal opportunity company.

About the role

You will work closely with the VP of Market Access & Clinical Research on the following workstreams. Your responsibilities will be:

Clinical research project management

• Lead study start-up process, including but not limited to coordinating the finalisation of Site Agreements, ethics / regulatory approvals and coordination of software setup and user training
• Proactively manage scientific and operational aspects of studies
• Provide updates on study progress including ensuring that study risks are escalated to the attention of the trial management group when appropriate
• Help develop and compile effective standard operational procedures (SOPs) and project management documentation
• Ensure high quality project delivery through site monitoring as well as protocol and SOP compliance
• Help coordinate dissemination activities for studies

Your initial focus in this capacity will be on managing Optellum’s DOLCE study funded by NHSX (more information can be found at https://optellum.com/2021/06/ai-software-will-help-clinicians-diagnose-lung-cancer-earlier/).

Clinical research planning and development

• Help devise plans for evaluating Optellum products that align with regulatory and reimbursement plans
• Support the development and submission of proposals for funding or collaboration partnerships
• Develop and execute plans for real-world evidence gathering at existing customer sites
• Assist legal counsel in the development of master research agreements for new clinical research projects
• Develop / support development of study protocols and other study documentation, e.g., Case Report Forms

About you

We are looking for somebody who has a thorough understanding of the clinical trial process as well as excellent collaborator and stakeholder management skills.

You will need:

• Clinical research experience:
  • You have helped set up and run prospective multisite clinical research studies including site monitoring (for protocol / SOP compliance)
  • You have put together study documentation including but not limited to standard operating procedures and those needed for HRA IRAS submissions in the UK
  • You have worked closely with clinicians and academics on clinical research projects or grant applications

• Excellent attention to detail: you pride yourself on your ability to spot crucial errors in technical documentation yet able to prioritise progress over perfection
• Ownership mindset: you have a willingness to learn “on the job”, as well as handle tight deadlines and multiple simultaneous responsibilities to get things done
• Collaborator and stakeholder management: you are effective at communicating with and coordinating inputs from multiple stakeholders and collaborators
• Travel: willingness and ability to occasionally travel to study sites within the UK if needed
• Qualifications: you have a university degree and are eligible to work in the UK

The following would be considered a plus:

• 2+ years of clinical research experience at a sponsor, CTU or CRO company
• Diagnostic medical device experience or experience in the respiratory field

In your application, provide 2-3 bullets about your motivations for joining us, your relevant experience and when you would be available to start.