Clinical Trial Manager
Better Therapeutics, United States
Job Description
The Company
Better Therapeutics is a prescription digital therapeutics (PDT) company delivering a novel form of cognitive behavioral therapy to address the root causes of cardiometabolic diseases. We have developed a proprietary platform for the development of FDA-regulated, software-based therapies for type 2 diabetes, heart disease and other conditions. The cognitive behavioral therapy delivered by our PDT enables changes in neural pathways of the brain so lasting changes in behavior become possible. Addressing the underlying causes of these diseases has the potential to dramatically improve patient health while lowering healthcare costs. Addressing the underlying causes of these diseases has the potential to dramatically improve patient health while lowering healthcare costs.
Better Therapeutics’ clinically validated mobile applications are intended to be prescribed by physicians and reimbursed like traditional medicines. Our pipeline includes products for people with type 2 diabetes, hypertension (high blood pressure) and hyperlipidemia (high cholesterol). We are currently enrolling our pivotal trial for BT-001, an investigational therapeutic for type 2 diabetes.
We are a well-funded startup, founded in 2015, and headquartered in San Francisco, CA. As of 2020, we permanently shifted to fully distributed (remote) operations.
The Role
We are looking for an experienced Clinical Trial Manager to join our team and make a major contribution by managing clinical trials of investigational digital therapeutics for patients and providers that aim to improve health outcomes, quality of life, and clinical decision-making, while reducing reliance on prescription medications and associated costs. You will collaborate with a talented team of clinicians, researchers, designers, engineers and product managers to manage the development and launch of clinical trials that evaluate efficacy and effectiveness of the products. In this role, you will also work closely with product managers in engineering and design to coordinate the development of novel methods to enable data collection, program analytics and study implementation.
To succeed in this role, you must be able to operate with a great deal of autonomy; be the consummate team player and help out anywhere, at any time; and be able to think 10 steps ahead while executing the next step with precision.
What you will do
- Assist in the development and drafting of clinical study protocols, study plans, ICFs and case report forms;
- Preparation and management of submissions to institutional review boards;
- Oversee the recruitment and enrollment of study participants;
- Supervise study sites and activities to ensure adherence to study protocols;
- Develop and maintain interim reports on study implementation (screening, enrollment, withdraws) and program adherence (analytics for the digital therapies);
- Assist in the evaluation of external vendors providing digital solutions for study activities (recruitment, enrollment, data collection) and manage vendor relationships;
- Collaborate with internal multidisciplinary teams in the development of novel workflows and digital solutions for the collection and monitoring of high quality study data;
- Serve as the primary contact between the Clinical Research team and Product, Design and Engineering teams;
Requirements
What you bring
- Clinical research experience with a variety of study types, including usability, phase 1 / 2, and real world studies. Previous work in digital health and virtual studies is a plus;
- Direct experience with end-to-end trial management;
- Experience partnering with multidisciplinary teams to create novel workflows to support research;
- Highly analytical with the ability to use both qualitative insights and quantitative findings to inform the development process;
- Excellent communication and collaboration skills;
- Knowledge of the clinical terms used in the diagnosis and treatment of cardiometabolic conditions. Direct experience working with behavioral interventions in an area of cardiometabolic health is a plus;
- Well-versed in ICH/ GCP requirements
Who you are
- You are driven by a sense of purpose, and possess a confidence, competence, and willingness to be accountable
- You are fascinated by technology and the way it transforms the way people live and work
- You are not intimidated by the fast-paced, dynamic characteristics of startups
- You know what a growth mindset is, and it embodies the way you live your life
- You are always up for a new challenge, not afraid to fail, and insatiably curious
- You have the intellect to grasp complex ideas, a thirst for learning, and the c