Senior Trial Manager

Our missionWe're powering biology's century with radically faster, more reliable clinical trials. Every new treatment needs clinical trials to prove safety and efficacy, but today's infrastructure is stuck in the past- driving up cost, causing delays and ultimately meaning new treatments don't get to patients. We're fundamentally changing that- not just being a "better CRO," but transforming how people think about developing new treatments, so patients can access breakthrough treatments faster.Our impact speaks for itself: Since March 2021, we've powered 100+ clinical trials involving tens of thousands of patients. We recently raised a $55M Series B from Balderton Capital, alongside backing from Creandum, Firstminute, Seedcamp, and Visionaries.What's it like to work here?When you join us, you'll experience:High-Impact, Mission-Driven Work: Lindus Health is disrupting an outdated industry, giving you the chance to directly improve patients' lives and see tangible results from your work.Fast-Paced Growth & Ownership: We recognise hard work and outcomes over anything else. You'll take on real responsibility, work across different areas, and actively shape the company's success.Collaborative, No-Ego Culture: Work with smart, driven people in a supportive and informal environment. At Lindus we break down silos, fun is a core value, and creativity is encouraged.Ready to power biology's century? We'd love to hear from you.We'd like to hear from you if:You have meaningful experience working on German drug trials and are business proficient in speaking GermanYou can evidence a strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring proceduresYou have >4 years' experience of end-to-end management and coordination of clinical trials in a project management and/or clinical operations role, including line management experienceYou're experienced in study start-up and EC/IRB applicationsYou've used different software for delivery of clinical trials and are able to adapt to using new technology to change the way trial processes are deliveredYou've worked on and have a strong understanding of decentralised/remote trialsYou've run multi-site and IND/CTIMP trialsYou're comfortable taking a hands-on, in-the-weeds approach to trial deliveryExperience with DiGa trials is a plusExperience of working in a startup/biotech is a plusWhat 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 successful delivery (i.e., conduct trials on time, on budget, in compliance, and of high quality)Provide oversight and management for 3-5 trials simultaneouslyAct as the primary liaison between Lindus Health and the Sponsor to ensure project launch, conduct, and closeout according to the Sponsor's and Lindus Health's contractual agreementManage sponsor relationships and serve as their key point of contactCoordinate activities and deliverables of all project partners and proactively identify and manage issuesTeam Leadership:Direct the activities of assigned Project Support staff and mentor other project management team members and clinical staff; facilitate team building and communicationReporting and Communication:Accountable for the maintenance of project information on a variety of databases and systemsMaintain and evaluate project progress by maintaining the timeline and other tracking/analysis toolsResponsible for the project management components of inspection readiness for all aspects of project conduct, including Trial Master FilesProvide oversight for the development and implementation of project plans in accordance with Lindus Health's standard operating proceduresDevelop contingency planning and risk mitigation strategies to ensure successful delivery of project goalsTraining:Facilitate team training in accordance with protocol and/or project requirements, including therapeutic, protocol-specific, and process trainingCollaboration: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 policiesBusiness Development:Support business development work with Sponsors and vendors where necessaryWhat we offer (EU)29 days of annual leave plus public holidays60 EUR monthly wellness allowance that you can spend flexiblyAccess to gym and retail discounts through our benefits platform HapplEnhanced parental leave - 16 weeks full pay for primary caregiver, followed by 23 weeks at statutory rate in the UK & 6 weeks full pay for secondary caregiverMonthly meal voucher for our remote teamsRegular company-wide and team events, both in-person and virtual1,000 EUR learning and development allowance per year for courses, certifications and further educationOur hiring processInitial interview with Cam (Talent Partner) (15 mins)Second meeting with a member of the Clinical Operations Team (30 mins)Interview with 2 members of the Clinical Operations team (45 mins)Values interview with one of our Co-Founders and one additional team member (30 mins)