Clinical Operations Lead, Clinical Studies Platform, EMEA
- Experience Level
- Experienced (non-manager)
Verily, an Alphabet company, lives at the intersection of technology, data science and healthcare. Our mission is to make the world’s health data useful so that people enjoy longer and healthier lives.
Our team combines expertise in healthcare, data science and technology to improve the health and well-being of our communities. We are developing the infrastructure and solutions to harness the profusion of health information for good. Our data-driven solutions span three primary areas: research, care and innovation. Programs include Project Baseline - our research initiative to increase participation and evidence generation in clinical research; Onduo - our personalized virtual care platform, which includes connected tools, lifestyle coaching and clinical support; and Debug - our effort to reduce the threat of mosquito-borne diseases by combining machine learning with sterile insect technique. We’re also actively working to combat the spread of COVID-19 through new programs like Healthy at Work.
Verily is working to make it easy and engaging for people to contribute to the map of human health and participate in clinical research. Together with researchers, clinicians, engineers, designers, advocates, and volunteers, we're collaborating to design the next generation of healthcare tools and services.
As a Clinical Operations Lead, you will leverage your strengths in clinical research to improve the way clinical studies are conducted and evidence is generated using advanced software and sensor technology.
We need an individual who is skilled in a range of clinical study designs, has excellent collaboration and negotiation skills, and is intellectually curious about decentralized clinical trials and new ideas for how to deploy them within the regulated research setting. You have outstanding people skills and have demonstrated your ability to coach your team members or co-workers.
- Oversee all operational aspects for the implementation of clinical study activities, including management of individual study activities, as needed, ensuring Good Clinical Practices (GCPs) and relevant Standard Operating Procedures (SOPs) are met.
- Implement cross-functional risk evaluation, mitigation, and management strategies aligned with Verily and partner risk management frameworks.
- Collaborate closely with Verily’s cross-functional product teams and external partners to develop and deploy compliant technology solutions for the conduct of clinical studies.
- Improve the operational delivery of clinical studies by closely aligning and developing processes with multidisciplinary stakeholders (product, UX, legal, quality, regulatory, etc.)
- Bachelors Degree in health or life science (BS/BA/ BScN or higher) is required.
- 8+ years independent clinical study management experience, preferably in pharmaceutical or biologics development.
- Advanced knowledge of Good Clinical Practices and current knowledge of EMA, MHRA, and other European regulations for clinical studies.
- Experience in study project management and prior management of contracted resources/CROs is required.
- 5+ years of experience working in Europe.
- Willingness to travel.
- 10+ years of work experience and/or Masters level degree in health or life science.
- Experience in site monitoring and/or clinical quality compliance.
- Experience managing a clinical operations team with excellent interpersonal, communication, negotiation, and collaboration skills.
- Experience deploying novel technologies in clinical studies and/or proven ability to navigate and manage decision-making in ambiguous situations.