Trial Manager
Trial Manager
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Salary Not Disclosed
1 Vacancy
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 to support the management and delivery of clinical trials to our German and/or French clients. 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 have meaningful experience working on German and/or French clinical trials.
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 from end to end in a project management and/or clinical operations role
You have experience of conducting study startup and EC/IRB applications
Youre capable of using different software for the 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 conducted multisite and IND/CTIMP trials
Previous experience of working in a startup/biotech is a plus
Knowledge of the German language
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 are delivered successfully (i.e. conduct trials on time on budget in compliance and of high quality)
Act as the primary liaison between Lindus Health and the Sponsor to ensure project launch conduct and closeout is run according to the Sponsors and Lindus healths contractual agreement
Coordinate the activities and deliverables of all project partners and proactively identify and manage issues that may arise
Reporting and Communication:
Accountability for the maintenance of project information on a variety of databases and systems
Maintain and evaluate 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
Provide oversight for development and implementation of project plans in accordance with Lindus Healths standard operating procedures
Direct the activities of assigned Project Support staff and mentor other project management team members and clinical staff; support team building and communication
Develop contingency plans and risk mitigation strategies to ensure successful delivery of the project goals
Training:
Facilitate team training in accordance with the 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
Business development:
Support business development work with Sponsors and vendors where necessary
What we offer
Unlimited holidays; everyone is encouraged to take off at least 28 days each year
60 EUR monthly wellness allowance which you can spend on 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 EUR 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
Monthly lunch voucher for our remote teams
Charity events and fundraising opportunities through our charity partnership with the Forward Trust
Our hiring process
Initial interview with Sarah (Talent Partner) 15 mins)
Second meeting with someone from the Clinical Operations Team 30 mins)
Interview with Emma and 2 members of the ClinOps team 45 mins)
Values interview with 23 members of our Founding team. We also use standardised testing as a complement to our final values interviews.
Required Experience:
Manager
Employment Type
Full-Time
