Senior Trial Manager

Senior Trial Manager

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 able to adapt to using new technology to change the way trial processes are delivered
• run multi-site and IND/CTIMP trials

Responsibilities

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

Preferred Qualifications

• Previous startup/biotech experience is a plus