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 recruiting a new Senior Trial Manager to support the delivery of clinical trials.
The primary responsibility of the senior trial manager 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.
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
About you
You should have:
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 Director of Clinical Operations
Culture and values interview with 2-3 members of our founding team
In person meeting with founders