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Lindus Health

Senior Trial Manager

Reposted 5 Days Ago
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Remote
Hiring Remotely in United States
Senior level
Remote
Hiring Remotely in United States
Senior level
Lead and oversee clinical trial programs, ensuring they are completed on time and within budget, while also managing a small team and collaborating with various stakeholders.
The summary above was generated by AI

🍊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  • High-Impact, Mission-Driven Work: Lindus Health is disrupting an outdated industry, giving you the chance to directly improve patients’ lives and see tangible results from your work.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 oversee the delivery of our expanding portfolio of CTIMP and non-CTIMP clinical trials, ensuring successful execution on time, on budget, and in full compliance with regulatory standards.

You will serve as the primary liaison between Lindus Health and our Sponsors, taking full accountability for project launch, conduct, and closeout activities while managing all project partners and proactively addressing any issues that arise.

This role is critical to our growth as we scale our clinical operations and requires someone who can thrive in a fast-paced startup environment, leading a small team of clinical operations professionals while directly contributing to our clinical strategy as an early member of the team.

You'll collaborate extensively with our Technology and Product teams to help design industry-leading trial technology solutions, work with Quality Management to develop rigorous validation standards, 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.


🍊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 clinical monitoring procedures

  • You have >6 years' experience managing and co-ordinating clinical trials in a project management and/or clinical operations role

  • You're experienced in leading and line-managing a team

  • You have experience with study start-up, closeout and EC/IRB 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 run multi-site and IND/CTIMP trials

  • 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 Delivery

  • Lead and manage the day to day oversight 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 point of contact between Lindus Health and the Sponsor to ensure project launch, conduct, and closeout according to the Sponsor’s and Lindus health's contractual agreement

  • Be accountable for 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

People Management

  • Manage a small team of clin ops professionals in a matrix environment

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 (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

    • Unlimited holidays (minimum 28 days encouraged)

    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

Top Skills

Clinical Trial Software
E-Consent
Edc
Etmf

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