Senior Trial Manager

🍊Our mission 

All new medicines need to undergo clinical trials to show they’re safe and effective. But today’s clinical trial infrastructure is stuck in the past, and the cost of developing new medicines has skyrocketed as a result. Patients have to wait longer and pay more for new treatments. 

Our mission is to fix this; we use software to help innovative companies run faster, more reliable, and patient-friendly clinical trials. We’re still a young company, but we’ve already had a big impact. Since founding the company 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 raised a $55m Series B round from Balderton Capital, with support from Creandum, Firstminute, Seedcamp, and Visionaries. 

🍊About you 

We’d like to hear from you if…

• You bring strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and monitoring procedures

• You have >6 years' experience in clinical trial set-up and start-up activities in a project management and/or clinical operations role

• You have experience of clinical trial conduct and close-out phases (essential for understanding full trial lifecycle)

• Able to operate independently, in a rapidly changing environment, and contribute to process development or scale-up initiatives.

• You're experienced in cross-functional collaboration and communication

• You have deep expertise in study start-up activities and EC/IRB and FDA applications

• You have 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

• You've managed multi-site and IND trial set-up processes

• Previous startup/biotech experience is a plus

You belong here! If your experience and interests match with some of the above, we want you to apply.

🍊What you’ll focus on

Project Leadership and Set-up Delivery:

• Lead and manage the set-up phase of FDA-regulated drug/device trials and non-IND clinical trial programs, ensuring successful trial initiation (on time, on budget, in compliance, and of high quality)

• Act as primary point of contact between Lindus Health and the Sponsor during trial set-up phase to ensure project launch according to contractual agreements

• Be accountable for set-up activities and deliverables of all project partners and proactively identify and manage issues during the initiation phase

• Oversee study start-up activities including site selection, site initiation visits, regulatory submissions, and EC/IRB applications

Reporting and Communication:

• Maintain project information on a variety of databases and systems during set-up phase

• Track and evaluate project progress by maintaining set-up timelines and other tracking/analysis tools

• Ensure inspection readiness for all aspects of trial set-up, including Trial Master File preparation

• Provide oversight for development and implementation of set-up plans in accordance with Lindus Health standard operating procedures

• Collaborate effectively with assigned Project Support staff and mentor other team members; facilitate cross-functional communication

• Develop contingency planning and risk mitigation strategies to ensure successful delivery of set-up goals

Training:

• Facilitate team training in accordance with protocol and/or project requirements during set-up phase, 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 during set-up

• 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)

• Make an impact across all areas of our business and 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

• $800 monthly employer contribution towards insurance coverage through our PEO Trinet.

• $40 monthly wellness allowance with complete flexibility on how to spend this including opting in to Wellhub membership, expensing wellness items and more!

• Access to gym and retail discounts through our benefits platform Happl.

• Enhanced Parental Leave - 16 weeks full pay for primary care giver, followed by 23 weeks at the UK statutory rate & 6 weeks full pay for secondary care giver

• Monthly lunch voucher for our remote teams

• Regular whole company and team events, both in person and virtually!

• $2,000 Learning and Development allowance each year to put towards courses, certifications and development

• Regular charity events and fundraising opportunities through our charity partnership with the Forward Trust.

🍊Our hiring process 

• Initial conversation with Cam, ur ClinOps Talent Partner(30 minutes)

• Hiring Manager Interview with one of our AD of ClinOPs (30 minutes)

• Technical/functional interview with two members of our ClinOps leadership team(60 minutes) 

• Values interview with one of our co-founders and a member of executive leadership (30 minutes)