About us
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 80 clinical trials involving thousands of patients, with a customer NPS of 100.
We recently raised a $18m Series A round from some great investors including Creandum, Peter Thiel and Firstminute to power the next stage of our growth.
About the role
We’re looking for an experienced and detail oriented GCP Quality Manager to ensure the highest standards of quality and compliance at Lindus Health as we continue to scale-up. The ideal candidate will have a deep understanding of Good Clinical Practice, Regulatory Requirements, and General Quality Principles. The GCP Quality Manager will play a critical role in maintaining and supporting the quality of our Clinical Operations and Product Teams.
The GCP Quality Manager will lead on Quality Assurance, drawing on your experience in clinical research, protocol development, GCP and related audit and inspection requirements to support Lindus Health in improving health care through clinical trials.
The role will be based in London UK. You will work closely with the Director of Quality, and the VP of Clinical Operations.
About you
Our wishlist for this role looks something like this:
5+ years’ experience working in GCP Quality Role
Experience with ICH GCP and multiple regional areas, particularly MHRA and FDA
Ideally with experience in Sponsor and regulatory GCP audits
You have high agency and a bias for action
You are passionate and curious about our mission; changing how the healthcare industry operates and how new health treatments are developed
You want to experience work at a high-growth, mission-driven VC funded startup
You belong here! If your experience and interests match with some of the above, we want you to apply.
What you will do
Focus Area 1: Clinical Quality Management
Support in the development and implementation of quality assurance processes and procedures compliant with GCP and regulations
Keep up to date with national and international legislation, guidelines and customer practices and provide ad-hoc consolidated information to the Lindus Health Quality & Clinical Operation Team.
Ensure that Lindus Health and its delivered studies continue to meet all regulatory requirements.
Maintain accurate and up-to-date documentation relating to GCP and quality management processes and review Clinical Operations Team study documents in development to ensure they comply with current clinical trial regulations.
Focus Area 2: Auditing and Monitoring
Leading internal and supporting external audits and taking responsibility for preparing staff and trial materials for audits and inspections by Sponsors and regulatory bodies, supporting staff during audit/inspection and with any follow-up actions that may be required
Identify and assess risks associated with GCP and implement risk mitigation strategies by collaborating with cross-functional teams to address and resolve identified risks.
What we offer
Have an impact across all areas of our business and fix one of the world’s most broken industries
Competitive salary, plus generous stock options
Unlimited holidays; everyone is encouraged to take off at least 28 days each year
Flexible office arrangement; you are encouraged to work 3-4 days per week in our office in London (near London Bridge) when you start, but you are free work flexibly once you've had a chance to get to know everyone
Regular team events; recently we've been to Legoland, a Bake Off competition, and a football match (decided by popular vote)
Up to £1,000 per year towards courses and development
A new laptop as your main workstation and up to £500 towards setting up your home office
UK visa sponsorship if you’re not already eligible to work in the UK
Our interview process
CV screening stage
Initial interview with the Director of Quality (30 minutes)
Technical interview with the Director of Quality and VP Clinical Operations (60 minutes)
Culture and values interview with 2 team members of the Founding team (30 minutes)
We try to arrange for at-least one interview to be in-person so you can see our office and meet more of the team.
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