Job Description

Location Type: Remote Employment Type: FullTime

🍊 Our Mission

All new medicines need to undergo clinical trials to show they’re safe and effective. However, today’s clinical trial infrastructure is outdated, leading to skyrocketing development costs for new medicines. This results in patients waiting longer and paying more for new treatments. Our mission is to fix this by using software to help innovative companies run faster, more reliable, and patient-friendly clinical trials. Since our founding in March 2021, we’ve helped run over 100 clinical trials involving tens of thousands of patients, with a customer NPS of 100. We recently secured a $55 million Series B funding round from Balderton Capital, with support from Creandum, Firstminute, Seedcamp, and Visionaries.

🍊 About You

We would like to hear from you if you possess the following:

• Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process, and clinical monitoring procedures.
• More than 6 years of experience managing and coordinating clinical trials in a project management and/or clinical operations role.
• Experience in leading and line-managing a team.
• Experience with study start-up, closeout, and EC/IRB applications.
• Experience using various software for clinical trial delivery and the ability to adapt to new technologies to transform trial processes.
• Experience running multi-site and IND/CTIMP trials.
• Previous startup/biotech experience is a plus.

‍🍊 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 successful delivery (on time, on budget, in compliance, and of high quality).
• Act as the primary point of contact between Lindus Health and the Sponsor to ensure project launch, conduct, and closeout align with contractual agreements.
• Be accountable for the activities and deliverables of all project partners and proactively identify and manage issues.

Reporting and Communication:

• Maintain project information across various databases and systems.
• Track and evaluate project progress using timelines and other tracking/analysis tools.
• Manage project management components for inspection readiness across all aspects of project conduct, including Trial Master Files.
• Oversee the development and implementation of project plans in accordance with Lindus Health standard operating procedures.
• Direct the activities of assigned Project Support staff, mentor other project management team members and clinical staff, and facilitate team building and communication.
• Develop contingency planning and risk mitigation strategies to ensure successful delivery of project goals.

People Management:

• Manage a small team of clinical operations professionals in a matrix environment.

Training:

• Facilitate 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 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 for 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 activities with Sponsors and vendors as needed.

What We Offer:

• Make an impact across all areas of our business and help fix one of the world’s most broken industries.
• Competitive salary, plus meaningful stock options.
• Unlimited holidays; everyone is encouraged to take off at least 28 days each year.
• Health insurance coverage through our PEO Trinet.
• $40