Trial Manager

Reposted 2 Days Ago
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Hiring Remotely in United States
Remote
80K-120K
Mid level
Healthtech
The Role
Lead and manage clinical trial operations, coordinate with sponsors and project partners, ensure compliance, and oversee project delivery on time and budget.
Summary Generated by Built In

🍊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  • High-Impact, Mission-Driven Work: Lindus Health is disrupting an outdated industry, giving you the chance to directly improve patients’ lives and see tangible results from your work.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 are looking for an experienced Clinical Trial Manager (Lead) to join our growing team, offering an exciting opportunity for someone with 4+ years of experience in clinical trial management and operations within the biotech or pharmaceutical industry.

As a key member of our clinical operations team, you'll lead the end-to-end delivery of CTIMP and non-CTIMP clinical trials, working closely with sponsors, cross-functional teams, and cutting-edge technology platforms to revolutionize how clinical trials are conducted. You'll play a pivotal role in ensuring trials are delivered on time, on budget, and in full compliance with regulatory standards, while gaining valuable exposure to innovative decentralized trial technologies and methodologies that are transforming the clinical research landscape.
🍊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 (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

  • Initial conversation with a member of the Talent team (20 mins)

  • Second meeting with a member of the ClinOps team (30 mins)

  • Functional interview with a couple of the ClinOps team (45 mins)

  • Values interview with a Cofounder and a member of the leadership team (30 minutes)

  • Stakeholder virtual meeting with Emma Ogbrun, VP of Clinical Operations (15 minutes)

Top Skills

Clinical Monitoring Software
Decentralized Trial Technology
E-Consent
Edc
Etmf
Good Clinical Practice
Ich Guidelines
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The Company
HQ: London
109 Employees

What We Do

Lindus Health is an anti-CRO running radically faster, more reliable clinical trials for life science pioneers.

We do this thanks to a commercial model that aligns incentives (fixed-price quotes per study, with milestone-based payments), marrying a world-class clinical operations team with our unique software platform, and access to 30 million Electronic Health Records. We handle the end-to-end execution of clinical studies, including design, patient recruitment, clinical data capture, monitoring and project management.

We have helped over 100 sponsors run entire clinical studies across the US, UK, and Europe up to 2x faster than traditional CROs

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