Clinical Trial Manager

Who We Are

Verily is a subsidiary of Alphabet that is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, our purpose is to bring the promise of precision health to everyone, every day. We are focused on generating and activating data from a variety of sources, including clinical, social, behavioral and the real world, to arrive at the best solutions for a person based on a comprehensive view of the evidence. Our unique expertise and capabilities in technology, data science and healthcare enable the entire healthcare ecosystem to drive better health outcomes.

Description

We are open to considering candidates in South San Francisco, CA, Boston, MA, Raleigh, NC, or Dallas, TX for this role.

The Clinical Trial Manager will be an integral member of the growing Device Operations team within as Verily is seeking to improve the way clinical trials are conducted and evidence is generated using advanced software and sensor technology. In this role, you will oversee the planning and execution of clinical studies that are sponsored by Verily or an industry client, and include the deployment of one or more medical devices. You will interact closely with a variety of teams at Verily, as well as clients from industry. These studies will include overseeing external Clinical Sites or our internal Clinical Verily Site.

We are looking for an individual who is skilled in a range of clinical study designs, including remote, decentralized and hybrid approaches, has excellent collaboration and communication skills in a largely virtual environment, and is intellectually curious about new ideas for how to execute studies within the regulated research setting. Since Verily products include digital biomarkers, hardware sensors, software, and algorithm development, your experience in the medical devices space, and ability to manage different research programs will be an important aspect of the work. You have outstanding people skills and have demonstrated your ability to coach your team members or co-workers. 

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 drive clinical study planning, execution, and closeout to meet the needs of our external clients and clinical trial participants.

Responsibilities

• As a CTM, you will be responsible for coordinating cross-functional team members, external stakeholders, and activities across all geographies, liaising with project leadership to ensure that deliverables (timeline, quality, productivity) are met. You will 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. 
• Your role will implement cross-functional risk evaluation, mitigation, and management strategies aligned with Verily and client risk management frameworks. You will seek to improve the operational delivery of clinical studies by closely aligning and developing processes with multidisciplinary stakeholders (product, UX,  legal, quality, regulatory, etc.).
• 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, and site instructions. 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.
• 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. Perform and oversee site monitoring visits for clinical trials as needed. You will oversee international site activities, including inventory management of devices or drug IP and applicable accountability records.

Qualifications

• BS/BSN degree in health or biologic science, or equivalent practical experience.
• At least 3 years of clinical research experience in the medical device, biopharmaceutical or diagnostics industry, including 2 years of experience as a clinical study lead/project manager.
• Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for clinical trials. Experience in study project management and prior management of contracted resources/CROs is requ