Director of Clinical Operations (East Coast, USA)

Job description

About Us Our mission is to accelerate clinical research for the next generation of healthcare companies. Since being established in early 2021 in the UK we've been growing quickly and are now expanding to the US. We are recruiting our first Director of Clinical Operations based in the US (East-Coast, not restricted to the state of NY) to support the delivery of clinical trials. The primary responsibility of the Director of Clinical Operations is the management and delivery of clinical trials to our US and global clients. As one of the first Lindus Health team members in the US teamwork, integrity and high agency is 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. Supporting US and global business development initiatives and activities will be a key element of the role. 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 $2,000 per year towards courses and development Employee benefits program A new laptop as your main workstation and up to $1,000 towards setting up your home office ‍ About you You should have: Based in the USA (East Coast) 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 role Experience with study start-up and EC/IRB applications Ideally 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 Clinical operations 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 issues Reporting 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 goals Training Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training Collaboration 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 team Business development Support business development work with Sponsors and vendors where necessary ‍ Interview process Initial interview with one of the Lindus Health founders to present the company mission and vision and answer any of your questions Technical interview with the UK Director of Clinical Operations Culture and values interview with 2-3 members of our founding team In person meeting with founders