Full-Time

Trial Manager

Posted on 4/18/2024

Lindus Health

Lindus Health

11-50 employees

Provides end-to-end clinical trial services

Data & Analytics

Mid

Remote in USA

Required Skills
Communications
Management
Requirements
  • Strong knowledge of Good Clinical Practice\/ICH guidelines, regulatory requirements, drug development process, and clinical monitoring procedures
  • 4 years' experience managing and coordinating clinical trials in a project management and\/or clinical operations role
  • Experience in study start-up and EC\/IRB applications
  • Experience with different software for delivery of clinical trials and ability to adapt to using new technology
  • Experience with decentralized\/remote trials and multi-site and IND\/CTIMP trials
  • Previous startup\/biotech experience is a plus
Responsibilities
  • Lead and manage the day to day running of CTIMP and non-CTIMP clinical trial programs and projects
  • Act 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
  • Coordinate activities and deliverables of all project partners and proactively identify and manage issues
  • Accountable for maintenance of project information on a variety of databases and systems
  • Maintain and evaluate project progress by maintaining timelines and other tracking\/analysis tools
  • Provide oversight for development and implementation of project plans in accordance with Lindus Health standard operating procedures
  • Direct the activities of assigned Project Support staff and mentors other project management team members and clinical staff; facilitate team building and communication
  • Facilitate 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, a next-generation Clinical Research Organization (CRO), is an excellent workplace for individuals passionate about streamlining and enhancing the clinical trial process. By integrating a unique software platform with access to 30 million Electronic Health Records, this company markedly accelerates trial timelines, which can be up to three times faster than traditional methods. Furthermore, the comprehensive scope of their services, from study design to patient recruitment and data monitoring, offers employees a rich environment for professional growth in varied aspects of clinical research.

Company Stage

Series A

Total Funding

$23.5M

Headquarters

, New York

Founded

2021

Growth & Insights
Headcount

6 month growth

0%

1 year growth

31%

2 year growth

70%
INACTIVE