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Full-Time

Senior Trial Manager

Confirmed live in the last 24 hours

Lindus Health

Lindus Health

11-50 employees

Next-generation clinical trial services provider

Data & Analytics
Hardware
AI & Machine Learning
Biotechnology
Healthcare

Senior, Expert

Remote in USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Communications
Management
Requirements
  • strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures
  • >6 years' experience managing and co-ordinating clinical trials in a project management and/or clinical operations role
  • experienced in leading and line-managing a team
  • experience with study start-up, closeout and EC/IRB applications
  • 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
  • worked on decentralised/remote trials
  • run multi-site and IND/CTIMP trials
Responsibilities
  • 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
  • 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
  • Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
  • 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
  • Support business development work with Sponsors and vendors where necessary

Lindus Health, as an advanced Contract Research Organization (CRO), brings distinct advantages to the clinical trial industry by offering comprehensive end-to-end services, including study design, patient recruitment, clinical data capture, monitoring, and project management. Their unique software platform, integrated with access to 30 million Electronic Health Records, allows them to conduct trials up to three times faster than traditional methods. This efficiency not only propels them as an industry leader but also offers employees a dynamic and forward-thinking work environment where they can engage in cutting-edge clinical research processes.

Company Stage

Series A

Total Funding

$23.5M

Headquarters

London, United Kingdom

Founded

2021

Growth & Insights
Headcount

6 month growth

↑ 8%

1 year growth

↑ 67%

2 year growth

↑ 441%
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Simplify's Take

What believers are saying

  • Lindus Health's innovative approach and rapid trial execution can significantly accelerate the development and market entry of new medical devices, consumer health products, and diagnostics.
  • Strategic partnerships and high-profile advisory board members, such as Dr. Tim Garnett and Dr. Robert Langer, enhance the company's credibility and industry influence.
  • Their robust recruitment capabilities, leveraging digital marketing and EHR databases, enable faster and more diverse participant enrollment, improving trial outcomes and data quality.

What critics are saying

  • The company's rapid expansion and multiple 'All-in-One' offerings may strain resources and operational capacity, potentially impacting service quality.
  • Dependence on proprietary technology like Citrus™ could pose risks if the platform encounters technical issues or fails to scale effectively.

What makes Lindus Health unique

  • Lindus Health positions itself as the 'anti-CRO,' focusing on radically faster and more reliable clinical trials, setting it apart from traditional CROs.
  • Their proprietary eClinical platform, Citrus™, and extensive database of over 30 million EHRs provide a unique technological edge in patient recruitment and data management.
  • Lindus Health's comprehensive 'All-in-One' offerings for medical devices, consumer health, and diagnostics demonstrate their versatility and specialized expertise across various therapeutic areas.