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 the role
We are looking for an experienced Clinical Operations Manager to join our growing team, offering an exciting opportunity for someone with 4+ years of experience in clinical trial management and operations within the biotech or pharmaceutical industry.

As a key member of our clinical operations team, you'll lead the end-to-end delivery of CTIMP and non-CTIMP clinical trials, working closely with sponsors, cross-functional teams, and cutting-edge technology platforms to revolutionize how clinical trials are conducted. You'll play a pivotal role in ensuring trials are delivered on time, on budget, and in full compliance with regulatory standards, while gaining valuable exposure to innovative decentralized trial technologies and methodologies that are transforming the clinical research landscape.
🍊About you

We'd like to hear from you if...

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

• You have >4 years' experience managing and co-ordinating clinical trials in a project management and/or clinical operations role

• You're experienced in study start-up and EC/IRB applications

• You've used 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 worked on decentralised/remote trials

• You've run multi-site and IND/CTIMP trials

• Previous startup/biotech experience is a plus

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🍊What you'll focus on

Clinical operations

Project Leadership and Delivery

• 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

Reporting and Communication

• 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

Training

• Facilitates 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 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

Business development

• Support business development work with Sponsors and vendors where necessary

🍊What we offer

Make an impact across all areas of our business and fix one of the world’s most broken industries.

• Make an impact across all areas of our business and fix one of the world’s most broken industries

• 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

🍊Our hiring process

• Initial conversation with a member of the Talent team (20 mins)

• Second meeting with a member of the ClinOps team (30 mins)

• Functional interview with a couple of the ClinOps team (45 mins)

• Values interview with a Cofounder and a member of the leadership team (30 minutes)

• Stakeholder virtual meeting with Emma Ogbrun, VP of Clinical Operations (15 minutes)