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• High-Impact, Mission-Driven Work: Lindus Health is disrupting an outdated industry, giving you the chance to directly improve patients’ lives and see tangible results from your work.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

🍊About the role
We're looking for a Senior Trial Manager to lead and manage the critical set-up phase of our FDA-regulated drug/device trials and non-IND clinical trial programs, ensuring successful trial initiation on time, on budget, and in full compliance with regulatory standards.

You will serve as the primary liaison between Lindus Health and our Sponsors during the trial set-up phase, taking full accountability for initiation activities and deliverables while overseeing key start-up processes including site selection, site initiation visits, regulatory submissions, and EC/IRB applications.

This role is essential to our growth as we rapidly scale our clinical operations and requires someone who can operate independently in a fast-changing environment while contributing to process development and scale-up initiatives as an early member of our clinical operations team.

You'll collaborate closely with our Product team to help design industry-leading trial technology solutions, work with Quality to develop rigorous validation standards during set-up, and support business development efforts with Sponsors and vendors as needed.

This position offers the opportunity to make a significant impact across our business while helping to transform one of the world's most challenging industries through innovative clinical trial delivery and set-up excellence.
🍊About you 

We’d like to hear from you if…

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

• You have >6 years' experience in clinical trial set-up and start-up activities in a project management and/or clinical operations role

• You have experience of clinical trial conduct and close-out phases

• Able to operate independently in a rapidly changing environment, and contribute to process development or scale-up initiatives.

• You're experienced in cross-functional collaboration and communication

• You have deep expertise in study start-up activities and EC/IRB and FDA applications

• You have experience using 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 managed multi-site and IND trial set-up processes

• Previous startup/biotech experience is a plus

You belong here! If your experience and interests match with some of the above, we want you to apply.

🍊What you’ll focus on

Project Leadership and Set-up Delivery:

• Lead and manage the set-up phase of FDA-regulated drug/device trials and non-IND clinical trial programs, ensuring successful trial initiation (on time, on budget, in compliance, and of high quality)

• Act as primary point of contact between Lindus Health and the Sponsor during trial set-up phase to ensure project launch according to contractual agreements

• Be accountable for set-up activities and deliverables of all project partners and proactively identify and manage issues during the initiation phase

• Oversee study start-up activities including site selection, site initiation visits, regulatory submissions, and EC/IRB applications

Reporting and Communication:

• Maintain project information on a variety of databases and systems during set-up phase

• Track and evaluate project progress by maintaining set-up timelines and other tracking/analysis tools

• Ensure inspection readiness for all aspects of trial set-up, including Trial Master File preparation

• Provide oversight for development and implementation of set-up plans in accordance with Lindus Health standard operating procedures

• Collaborate effectively with assigned Project Support staff and mentor other team members; facilitate cross-functional communication

• Develop contingency planning and risk mitigation strategies to ensure successful delivery of set-up goals

Training:

• Facilitate team training in accordance with protocol and/or project requirements during set-up phase, 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 during set-up

• 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 (US)

We believe in rewarding the people who are building the future of clinical research.

• Financial & Growth:

  • Competitive salary plus meaningful equity - you'll own a piece of what we're building

  • $2,000 annual Learning & Development budget for courses, certifications, and conferences

  • 39 days annual leave (27 days PTO + 11 federal holidays + 1 James Lind Day)

  Health & Wellbeing:

  • $800 monthly employer contribution for insurance coverage (via Trinet PEO)

  • $40 monthly wellness allowance - gym, massage, whatever keeps you at your best

  • Enhanced parental leave: 16 weeks full pay for primary caregivers, 6 weeks for secondary

  • Access to gym and retail discounts through Happl

  Culture & Connection:

  • Monthly lunch vouchers for remote team members

  • Regular company events and team gatherings (both virtual and in-person)

  • Charity partnerships and volunteering opportunities with Forward Trust

  • Work with a team that's genuinely changing healthcare for the better

🍊Our hiring process

We believe hiring should be transparent, respectful of your time, and give you a real feel for what Lindus Health is like. Here's what to expect:

• Online Logical Reasoning and Problem Solving test (20 minutes)

• Initial conversation with Cam, our ClinOps Talent Partner (30 minutes)

  Get to know each other, discuss the role, and answer any questions about Lindus

• Second conversation with one of our AD of ClinOps (30 minutes)

  Deep dive into your experience and how you'd approach key challenges

• Technical/functional interview with an AD of ClinOps (45 minutes)

  This will include a task you’ll need to prepare in advance of the interview and talk to

• Values interview with 2 team members of leadership (30 minutes)

  A chance to get to know each other and explore how our values align

• Final Conversation with our VP of ClinOps (15 minutes)

  An opportunity to ask any remaining questions to the department head