Trial Manager
Trial Manager
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Job Description
Our mission
All new medicines need to undergo clinical trials to show theyre safe and effective. But todays 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 patientfriendly clinical trials. Were still a young company but weve already had a big impact. Since founding the company in March 2021 weve 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.
The primary responsibility of the Trial Manager is the management and delivery of clinical trials to our UK and global clients. As one of the early Lindus Health team members teamwork integrity and high agency are absolutely essential. A good working knowledge of the regulatory ethics and clinical operations requirements is a prerequisite. You will be required to work and contribute in an agile and innovative work culture.
About you
Wed like to hear from you if...
You bring strong knowledge of Good Clinical Practice/ICH guidelines regulatory requirements drug development process and clinical monitoring procedures
You have >4 years experience managing and coordinating clinical trials in a project management and/or clinical operations role
Youre experienced in study startup and EC/IRB applications
Youve 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
Youve worked on decentralised/remote trials
Youve run multisite and IND/CTIMP trials
Previous startup/biotech experience is a plus
What youll focus on
Project Leadership and Delivery:
Lead and manage the day to day running of CTIMP and nonCTIMP 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 Sponsors and Lindus healths 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 bestinclass trial technology that exceeds customer demands (e.g. EDC eConsent 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 worlds most broken industries.
Competitive salary plus meaningful stock options
Flexible working: We have an incredible office near London Bridge and encourage people to work 3 days per week from the office
Unlimited holidays; everyone is encouraged to take off at least 28 days each year
60 monthly wellness allowance which you can spend on our company health insurance scheme through AXA a wellhub membership or wellness activities and expenses of your choice!
Enhanced Parental Leave: 16 weeks full pay for primary caregiver and 6 weeks full pay for secondary caregiver
1000 Learning and Development allowance each year to put towards courses certifications and development
Regular whole company and team events both in person and virtually.
Access to gym and retail discounts through our benefits platform Happl
A wellstocked pantry and drinks fridge Monday breakfast spread and catered team lunch on a Thursday for the UK office every week!
Cycletowork scheme and other salary sacrifice options available
Charity events and fundraising opportunities through our charity partnership with the Forward Trust
Our hiring process
Initial conversation with a member of our Talent team 20 mins)
Second meeting with a member of our Clinical Operations team 30 mins)
Functional interview the ClinOps team 45 mins)
Values interview with 23 members of our Founding team. 2030 mins) We also use standardised testing as a complement to our final values interviews.
We try to arrange for atleast one interview to be inperson so you can see our office and meet more of the team.
Required Experience:
Manager
Employment Type
Full-Time
