Trial Manager (Germany)

Job description

About Us Lindus Health is a start-up with a mission to accelerate clinical research for the next generation of healthcare companies. We are recruiting for a Trial Manager to lead the delivery of German clinical trials within our portfolio. Join our team as one of our early hires to revolutionise the way clinical trials are delivered and bring new treatments to patients faster! The primary responsibility of the trial manager is the management and delivery of clinical trials to our global clients. As one of the early clinical operations team members, teamwork, integrity and high agency is absolutely essential. A good working knowledge of the regulatory, ethics and clinical operations requirements within Germany is a prerequisite. You will be required to work and contribute in an agile and innovative work culture. The role will also involve supporting global business development activities. 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 (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: Experience running and co-ordinating clinical trials in Germany in a project management and/or clinical operations role, and fluent in German Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures Experience with study start-up and ethics committee applications in Germany 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 trials under AMG and DiGA 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 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 conduct 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 Independently prepares, coordinates, and presents project material at internal and external meetings Directs the activities of assigned Project Support staff and mentors other project management team members and clinical staff; facilitates team building and communication Prepares project management reports for clients and management Implements resource strategies to achieve project goals 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 or one of the founders Culture and values interview with 2-3 members of our founding team In person meeting with members of the wider team ‍