Clinical Research Manager EMEA | Artificial Intelligence | SAMD
London, United Kingdom
Clinical Research /
Full-time
/ Remote
Note: We support remote working for this role to be based anywhere within the UK. We will also provide access to a co-working space.
About your role
As a Clinical Research Manager at Annalise.ai, you will play a vital role in the generation of clinical evidence to support software as medical device (SAMD) artificial intelligence (AI) products used in diagnostic medical imaging.
Reporting to the Head of Clinical Research & Medical Affairs, you will be responsible for the planning, management, and end-to-end conduct of clinical studies for Annalise. Your accountabilities will be across KOL/site engagement, protocol development, study management, healthcare economics analyses, statistical analyses, and clinical evaluation activities. This role will see you coordinate interactions between a range of internal and external stakeholders, so you will need strong written and verbal communication skills.
This is a highly commercial role that partners closely with our business development and sales teams and is directly client-facing.
This is an excellent opportunity to lead our clinical studies and support regulatory strategy within the growing field of applied AI involving SAMD.
As we pioneer new ways of improving health delivery at scale using the most cutting-edge AI technologies, we invite you to consider an exciting, meaningful career with us here at Annalise.ai as a Clinical Research Manager.
What you'll do:
- Conduct study management, including concept development, protocol writing, SOL/site engagement, report writing/review, statistical analysis, and presentation/publication;
- Together with the commercial team, participate in face-to-face and remote customer meetings to facilitate a deep understanding of their clinical practice, use case, evidence needs, and research experience;
- Monitor and lead ongoing risk management of assigned studies;
- Lead the delivery of project/product documentation (e.g., manuscripts, reports, study proposals, project plans, study protocols, literature reviews, and regulatory documentation);
- Effectively manage liaisons between external and internal stakeholders, e.g., lead clinicians, regulatory, quality, product, technical, and systems;
- Oversee and/or manage studies with external collaborators and oversee CROs and outsourced studies as required;
- Support Regulatory submissions/responses as required.
What will help you succeed:
- Solid experience in the clinical research field in the medical devices industry;
- Degree in health sciences, nursing, life science, medical science, engineering, or related field;
- Being comfortable in a highly commercial role, where you need to be directly client-facing and partnering closely with our sales and business development teams;
- Experience working with cross-functional teams and
- Strong knowledge of 21 CFR, ICH/GCP, ISO14155 2020 2017/745 (EU MDR) requirements.
Nice to have (but not essential):
- Advanced research degree (Masters/PhD);
- Experience working in research involving artificial intelligence, SAMD and/or medical imaging
- Experience performing statistical analysis and/or programming expertise
- Experience with Australian, European, and US medical device regulatory submissions
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