Senior 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. 

In August 2023 we raised an $18m Series A round from some of the world’s top investors including Creandum, Peter Thiel, Firstminute and Seedcamp to power the next stage of our growth. 

The primary responsibility of the Senior Trial Manager is the management and delivery of clinical trials to our German and/or French 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

We'd like to hear from you if...

• You have meaningful experience working on German and/or French clinical trials.

• You bring 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

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

• Make an impact across all areas of our business and fix one of the world’s most broken industries 

• Competitive salary

• Unlimited holidays; everyone is encouraged to take off at least 28 days each year

• Enhanced Parental Leave- 12 weeks full pay

• Regular team events; recently we've been to Legoland, a Bake Off competition, and a Millwall FC home game (decided by popular vote)

• Up to £1,000 euro equivalent per year towards courses, certifications and development

🍊Our hiring process

• Initial interview with George (Director, Talent) (30 mins)

• Second meeting with Emma (VP, Clinical Operations) (30 mins)

• Interview with Emma and 2 members 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.