Sr. 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 candidates in Dallas, TX, South San Francisco, CA, Raleigh, NC, and Boston, MA for this role.

The Sr. Clinical Trial Manager will be an integral member of the growing Sponsor Operations team at Verily. 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 Verily solutions and deployment of one or more medical devices. You will partner closely with a variety of teams at Verily, as well as partners from industry. 

As a Sr. Clinical Trial Manager on Verily’s Sponsor Operations team, you will lead cross functional teams in clinical study design, planning, and execution (start-up to close-out). You will be accountable for overseeing study deliverables and work streams, ensuring relevant practices (e.g. Good Clinical Practices, Good Pharmacoepidemiology Practices, Common Rule) and relevant Standard Operating Procedures (SOPs) are met as required. 

Responsibilities

• Oversee all operational aspects for the implementation of clinical study activities from study start-up through database lock, ensuring relevant practices (e.g. Good Clinical Practices, Good Pharmacoepidemiology Practices, Common Rule) and relevant Standard Operating Procedures (SOPs) are met.
• Work closely with cross-functional teams on clinical study delivery for Verily sponsored and externally Sponsored research projects. Provide input for developing study-related materials, such as Monitoring Plans, Trial Master File Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, informed consent, site instructions/training, and other aspects of study operations.
• Review monitoring/data reports, protocol deviations to ensure reliable quality data is delivered; coordinate/manage Contract Research Organizations (CROs) on site selection, Institutional Review Board (IRB) submissions, site initiation and close-out planning.
• Directly overseeing external clinical sites and/or our internal Verily clinical site (onboarding and initiation through close-out).
• Communicate directly with study site staff and investigators; track patient recruitment and progress to study timelines; support safety reporting and IRB submissions; maintain and report metrics for clinical site performance.

Qualifications

Minimum Qualifications:

• BA/BS/BScN degree in health or biologic science, or equivalent practical experience.
• Experience in study project management and prior management of contracted resources/CROs/Sites.
• 8+ years experience in medical device development and study management.

Preferred Qualifications:

• 8+ total years of clinical study management experience in registries, observational research, RWD/E, and medical device research as a clinical study lead/project manager.
• Master's degree in health or biologic science, or equivalent practical experience.
• Experience managing decentralized clinical trials (DCTs) and deploying DCT solutions. 
• Experience with RWD/E generation research (e.g., registries, observational research, RWD collection).
• Experience in site monitoring, clinical quality compliance and international study management. Strong working knowledge of Good Clinical Practices, Good Pharmacoepidemiology Practice and current knowledge of FDA regulations for human subjects research.

The US base salary range for this full-time position is $124,000 - $190,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring pr