GCP Quality Associate

🍊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 80 clinical trials involving tens of 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:

Seeking a detail-oriented GCP Quality Associate to drive our commitment to the highest standards of quality and compliance as we scale up operations. The successful candidate will bring understanding of Good Clinical Practice (GCP) and a curiosity for Clinical Trials Quality Principles. We’re open to experience on this hire- if you’re a Trial Coordinator or a CRA with a deep interest in pivoting to a GCP role this could also be an interesting opportunity for you. This role is situated in London, UK, and involves close collaboration with our Associate Director of GCP and Quality, and VP of Clinical Operations.

🍊About You:

We encourage applications from candidates who:

• Have a minimum of 2 years experience working to GCP principles.

• Possess knowledge of ICH GCP and ideally other regional areas, with a focus on MHRA- FDA experience.

• Possess an understanding of Sponsor and regulatory GCP audits.

• Exhibit high agency and a proactive attitude.

• Share a deep passion and curiosity for Lindus Health’s mission of transforming healthcare operations and advancing new health treatments.

• Desire to contribute to the dynamic environment of a high-growth, mission-driven, venture-capital-funded startup.

🍊What You’ll Focus On:

• Clinical Quality Management:

  • Support the development and implementation of quality assurance processes and procedures compliant with GCP and regulations.

  • Stay updated on national and international legislation, guidelines, and customer practices, providing consolidated information to the Lindus Health Quality & Clinical Operation Team.

  • Help to ensure Lindus Health and its delivered studies consistently meet all regulatory requirements.

  • Support maintenance of accurate and up-to-date documentation related to GCP and quality management processes.

  • Review study documents within the Clinical Operations Team to ensure compliance with current clinical trial regulations.

• Auditing and Monitoring:

  • Support internal and external audits, providing support for external audits, preparing staff and trial materials for inspections by Sponsors and regulatory bodies.

  • Support staff during audits/inspections and manage any required follow-up actions.

🍊What We Offer:

• Make an impact across all areas of our business and fix one of the world’s 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

• Health & wellbeing - cashback scheme with Medicash (unlimited virtual GP appointments, medical, dental, optician, physio, mental health + more!)

• Gympass membership; flexible access to gyms, studios, classes and wellness apps

• Enhanced Parental Leave - 12 weeks full pay for primary care giver & 4 weeks full pay for secondary care giver

• Cycle to work scheme

• Regular team events; recently we’ve been to Legoland, a Bake Off competition, and a Millwall FC home game (decided by popular vote)

• Up to £1,000 per year towards courses, certifications and development

🍊Our hiring process

• Initial interview with Stasya (Associate Director of GCP and Quality)  (30 minutes)

• Technical interview with Stasya, a senior member of our ClinOps team and Emma (VP, Clinical Operations) (45 minutes)

• Values interview with 2 members of the Founding team (30 minutes)