- Bachelor's degree or equivalent practical experience.
- 7 years of experience in clinical research operations.
- 7 years of experience with medical devices, software as a medical device (SaMD) products, pharmaceuticals, and/or healthcare interventions.
- Experience or interest in supporting virtual clinical studies that leverage smartphones, mobile devices, and/or other digital health data.
- Experience in executing a range of clinical study designs.
- Knowledge of FDA and ICH Good Clinical Practice (GCP) regulations governing the conduct of clinical trials and processes, and related regulatory requirements and terminology.
About the job
A problem isn’t truly solved until it’s solved for all. That’s why Googlers build products that help create opportunities for everyone, whether down the street or across the globe. As a Program Manager at Google, you’ll lead complex, multi-disciplinary projects from start to finish — working with stakeholders to plan requirements, manage project schedules, identify risks, and communicate clearly with cross-functional partners across the company. Your projects will often span offices, time zones, and hemispheres. It's your job to coordinate the players and keep them up to date on progress and deadlines.
Our goal is to build a Google that looks like the world around us — and we want Googlers to stay and grow when they join us. As part of our efforts to build a Google for everyone, we build diversity, equity, and inclusion into our work and we aim to cultivate a sense of belonging throughout the company.
As Lead Clinical Research Operations Program Manager, you will drive operations and manage excellence in digital health research studies, including development of clinical study platforms, digital health endpoints, and methods. You will work with Clinical Research teams across Google including study investigators, research scientists, data scientists, and clinical research operations specialists to design and conduct clinical studies across the lifecycle of Google programs.
Google Health has made major advances in healthcare research, such as detecting eye disease more quickly and accurately than experts, planning cancer radiotherapy treatment in seconds rather than hours, and working to detect patient deterioration before it happens with electronic records.
Fundamental research is at the core of Google Health - the multidisciplinary team collaborates with partners to publish novel research in renowned scientific journals. They then work to apply this research into the medical field through clinical hardware and products developed in Google. Working alongside colleagues across Google, you’ll help make this vision a reality.
(Colorado only*) Minimum salary of $137,000 + bonus + equity + benefits .
*Note: Disclosure as required by sb19-085 (8-5-20) of the minimum salary compensation for this role when being hired into our offices in Colorado.
- Grow clinical research executional capacity including staffing requirements, optimize processes for study approvals and management, and disseminate best practices to enable growth and scalability of digitally-enabled clinical research programs across Google.
- Work with teams to grow collaborative relationships across Google, and work with external partners including academic/industry partners, study investigators, clinical research sites, Contract Research Organizations (CROs) and vendors to execute excellent clinical research studies.
- Manage operational aspects for the execution of pioneering digital health study activities from study start-up, through study closure while ensuring adherence to protocol, standard operating procedures, and applicable regulatory requirements.
- Manage the development of study-specific documents such as study protocols, IRB submissions, research agreements, study training materials, and trial master files, and for studies involving clinical sites, manage processes including site qualification, initiation, monitoring, site metrics, and closeout visits.