Senior Trial Manager

🍊Our mission 

We're powering biology's century with radically faster, more reliable clinical trials. Every new treatment needs clinical trials to prove safety and efficacy, but today's infrastructure is stuck in the past- driving up cost, causing delays and ultimately meaning new treatments don’t get to patients. We're fundamentally changing that- not just being a "better CRO," but transforming how people think about developing new treatments, so patients can access breakthrough treatments faster.

Our impact speaks for itself: Since March 2021, we've powered 100+ clinical trials involving tens of thousands of patients. We recently raised a $55M Series B from Balderton Capital, alongside backing from Creandum, Firstminute, Seedcamp, and Visionaries.

🍊What's it like to work here?

When you join us, you’ll experience:

• High-Impact, Mission-Driven Work: Lindus Health is disrupting an outdated industry, giving you the chance to directly improve patients’ lives and see tangible results from your work.

• Fast-Paced Growth & Ownership: We recognise hard work and outcomes over anything else. You’ll take on real responsibility, work across different areas, and actively shape the company’s success.

• Collaborative, No-Ego Culture: Work with smart, driven people in a supportive and informal environment. At Lindus we break down silos, fun is a core value, and creativity is encouraged.

Ready to power biology's century? We'd love to hear from you.

We'd like to hear from you if:

• You have meaningful experience working on German drug trials and are business proficient in speaking German

• You can evidence a strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures

• You have >4 years' experience of end-to-end management and coordination of clinical trials in a project management and/or clinical operations role, including line management experience

• 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 and have a strong understanding of decentralised/remote trials

• You've run multi-site and IND/CTIMP trials

• You're comfortable taking a hands-on, in-the-weeds approach to trial delivery

• Experience with DiGa trials is a plus

• Experience of working in a startup/biotech 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 successful delivery (i.e., conduct trials on time, on budget, in compliance, and of high quality)

• Provide oversight and management for 3-5 trials simultaneously

• Act as the 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

• Manage sponsor relationships and serve as their key point of contact

• Coordinate activities and deliverables of all project partners and proactively identify and manage issues

Team Leadership:

• Direct the activities of assigned Project Support staff and mentor other project management team members and clinical staff; facilitate team building and communication

Reporting and Communication:

• Accountable for the maintenance of project information on a variety of databases and systems

• Maintain and evaluate project progress by maintaining the timeline and other tracking/analysis tools

• Responsible for the project management components of inspection readiness for all aspects of project conduct, including Trial Master Files

• Provide oversight for the development and implementation of project plans in accordance with Lindus Health's standard operating procedures

• Develop contingency planning and risk mitigation strategies to ensure successful delivery of project goals

Training:

• Facilitate 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

Business Development:

• Support business development work with Sponsors and vendors where necessary

🍊What we offer (EU)

• 29 days of annual leave plus public holidays

• 60 EUR monthly wellness allowance that you can spend flexibly!

• Access to gym and retail discounts through our benefits platform Happl

• Enhanced parental leave - 16 weeks full pay for primary caregiver, followed by 23 weeks at statutory rate in the UK & 6 weeks full pay for secondary caregiver

• Monthly meal voucher for our remote teams

• Regular company-wide and team events, both in-person and virtual!

• 1,000 EUR learning and development allowance per year for courses, certifications and further education

🍊Our hiring process

• Initial interview with Cam (Talent Partner) (15 mins)

• Second meeting with a member of the Clinical Operations Team (30 mins)

• Interview with 2 members of the Clinical Operations team (45 mins)

• Values interview with one of our Co-Founders and one additional team member (30 mins)