Trial Lead

**About us** All new medicines need to undergo clinical trials to show they’re safe and effective. But today’s clinical trial infrastructure is stuck in the past, and the cost of developing new medicines has skyrocketed as a result. Patients have to wait longer and pay more for new treatments. Our mission is to fix this; we use software to help innovative companies run faster, more reliable, and patient-friendly clinical trials. We’re still a young company, but we’ve already had a big impact. Since founding the company in March 2021 we’ve helped run over 80 clinical trials involving tens of thousands of patients. We raised a $6m seed round from some great investors including Firstminute, Peter Thiel and Seedcamp to power the next stage of our growth. The primary responsibility of the Trial Lead is the management and delivery of clinical trials to our UK and global clients. As one of the early Lindus Health team members teamwork, integrity and high agency are absolutely essential. A good working knowledge of the regulatory, ethics and clinical operations requirements is a prerequisite. You will be required to work and contribute in an agile and innovative work culture. **About you**- Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures- - >4 years' experience managing and co-ordinating clinical trials in a project management and/or clinical operations roleIdeally experience using different software for delivery of clinical trials and able to adapt to using new technology to change the way trial processes are delivered- - Ideally experience working on decentralised/remote trials- - Ideally includes experience of running multi-site and IND/CTIMP trials- - Previous startup/biotech experience is a plus - ‍**What you will do** Project Leadership and Delivery: - Lead and manage the day to day running of CTIMP and non-CTIMP clinical trial programs and projects, ensuring that they delivery successfully (i.e., conduct trials on time, on budget, in compliance, and of high quality)- - Acts as primary liaison between Lindus Health and the Sponsor to ensure project launch, conduct, and closeout according to the Sponsor’s and Lindus health's contractual agreement- - Coordinates activities and deliverables of all project partners and proactively identifies and manages issuesReporting and Communication: - Accountable for maintenance of project information on a variety of databases and systems- - Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools- - Responsible for project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files- - Provides oversight for development and implementation of project plans in accordance with Lindus Health standard operating procedures- - Directs the activities of assigned Project Support staff and mentors other project management team members and clinical staff; facilitates team building and communication- - Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goalsTraining: - Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process trainingCollaboration: - Work closely with the tech and product teams to help design best-in-class trial technology that exceeds customer demands (e.g., EDC, e-Consent, eTMF)- - Collaborate with Quality Management to develop formal study requirements that enable rigorous validation of clinical trial software, and contribute to the development and maintenance of our standard operating procedures and policies- - Contribute to our clinical strategy as an early employee of the clinical operations teamBusiness development: Support business development work with Sponsors and vendors where necessary **Why join the Lindus Health team?**- Be part of the founding team on a mission to change the way healthcare operates- - Competitive salary, plus generous stock options- - Unlimited holidays; everyone is encouraged to take at least 28 days off each year- - Hybrid working arrangement- - Up to £1,000 per year towards courses and development- - Employee benefits program- - A new laptop as your main workstation and up to £500 towards setting up your home office**Next steps and interview process**- Initial interview with our Head of Talent to present the company mission and vision and answer any of your questions- - Interview with the Director of Clinical Operations- - Interview with the Director of Clinical Operations and 2 members of the ClinOps team- - Culture and values interview with 2-3 members of our founding team- - In person meeting with founders