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. 

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

We'd 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 co-ordinating clinical trials from end to end in a project management and/or clinical operations role

• You have experience of conducting study start-up and EC/IRB applications

• You're 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

• You've worked on decentralised/remote trials

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

• Previous experience of working in a startup/biotech is a plus

• Knowledge of the German language
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🍊What you'll focus on

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 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 Sponsor’s and Lindus health's 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 Health's 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 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

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 2-3 members of our Founding team. We also use standardised testing as a complement to our final values interviews.