Trial Manager
Our mission 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, with a customer NPS of 100. We recently raised a $18m Series A round from some great investors including Creandum, Peter Thiel and Firstminute to power the next stage of our growth. About you We'd like to hear from you if...
- You have strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures
- You have >4 years' experience managing and co-ordinating clinical trials in a project management and/or clinical operations role
- You're experienced in study start-up and EC/IRB applications
- You've used different software for delivery of clinical trials and are able to adapt to using new technology to change the way trial processes are delivered
- You've worked on decentralised/remote trials
- You've run multi-site and IND/CTIMP trials
- Previous startup/biotech experience is a plus What you'll focus on 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 What we offer
- Have an impact across all areas of our business and fix one of the world’s most broken industries
- Competitive salary, plus meaningful stock options
- Unlimited holidays; everyone is encouraged to take off at least 28 days each year
- Enhanced Parental Leave- 12 weeks full pay
- Gympass membership; flexible access to gyms, studios, classes and wellness apps
- Expense your lunch 1 day per week
- Company away days - this year we went to Nashville!
- Up to $2000 per year towards courses and development
- A new laptop as your main workstation and up to $1000 towards setting up your home office Our hiring process
- Initial conversation with George (Director, Talent) (30 mins)
- Second meeting with Emma (VP, Clinical Operations) (30 mins)
- Functional interview with Emma and a couple of the ClinOps team (45 mins)
- Values interview with 2-3 members of our Founding team. We also use standardised testing as a complement to our final values interviews. Apply tot his job Apply To this Job
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