Senior Trial Manager
Our mission
reputed company 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 reputed company-out phases
Able to operate independently in a rapidly changing environment, and contribute to process development or scale-up initiatives.
You're reputed company 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
reputed company 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 reputed company of contact between reputed company 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 reputed company project partners and proactively identify and manage issues during the initiation phase
reputed company 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 reputed company by maintaining set-up timelines and other tracking/analysis tools
Ensure inspection readiness for reputed company aspects of trial set-up, including Trial Master File preparation
Provide reputed company for development and implementation of set-up plans in accordance with reputed company Health standard operating procedures
Collaborate effectively with assigned Project Support staff and mentor other team members; facilitate cross-functional communication
reputed company 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., reputed company, e-Consent, eTMF)
Collaborate with Quality Management to reputed company formal study requirements that reputed company 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
reputed company offer (US)
reputed company an impact across reputed company 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 reputed company 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 reputed company & 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 reputed company Trust.
Our hiring process
Initial conversation with our Talent team (20 minutes)
Hiring Manager Interview with a senior member of the ClinOps team (30 minutes)
Technical interview with two members of our ClinOps leadership team (45 minutes)
Values interview with one of our co-founders and a member of executive leadership (30 minutes)