Clinical Trial Manager Jobs

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.

Description

The Clinical Trial Manager will be an integral member of the growing Baseline team. With Project Baseline, Verily is seeking to improve the way clinical trials are conducted and evidence is generated using advanced software and sensor technology. In this role, your team will help to oversee the planning and execution of clinical studies utilizing the Baseline platform. You will interact closely with a variety of teams at Verily, as well as partners from industry.

Project Baseline is an initiative 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 CTM, you will work with teams across Verily to support clinical study planning and execution, utilizing Baseline tools and functionality to meet the needs of our external partners.

Responsibilities

• Perform and oversee site monitoring visits for clinical trials as needed. Facilitate site study device orders, and ensure site accountability records are maintained.
• Communicate directly with study site staff and investigators for clinical trials; track patient recruitment and progress to study timelines; support safety reporting and IRB submissions; maintain and report metrics for clinical site performance.
• Provide input for developing study-related materials, such as Clinical Monitoring Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, patient informed consent drafts, site instructions for specimen collections, and study device order forms.
• Review monitoring reports, protocol deviations and data listings for sponsored studies to ensure reliable quality data is delivered; coordinate with Contract Research Organizations (CROs) on site selection, Institutional Review Board (IRB) submissions, site initiation and close-out planning.
• Oversee all operational aspects for the implementation of clinical trial activities from study start-up through database lock, ensuring Good Clinical Practices (GCPs) and relevant Standard Operating Procedures (SOPs) are met. Work closely with Verily’s product teams to develop technology solutions to support the conduct of Clinical Trials.

Qualifications

Minimum Qualifications:

• Experience in study project management and prior management of contracted resources/CROs.
• BA/BS/BScN degree in health or biologic science, or equivalent practical experience.
• At least 6-8 years of clinical study management experience in medical device, biopharmaceutical or diagnostics industry, including 3 years of experience as a clinical study lead/project manager.

Preferred Qualifications

• Deep knowledge of the range of tools used in the clinical study management space.
• Master's degree in health or biologic science, or equivalent practical experience.
• Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for clinical trials.
• Experience in site monitoring, clinical quality compliance and international study management.