About the Clinical Research Manager (Headspace Health) at Headspace:

Headspace is looking for a Clinical Research Manager for Headspace Health, a newly formed digital therapeutics subsidiary company. Headspace Health aims to develop FDA-cleared digital therapeutic products to help mitigate and treat chronic health conditions. Reporting to the Director of Clinical Affairs of Headspace Health this individual will manage internal and external clinical studies in accordance with the applicable clinical and regulatory standards. This is a unique opportunity to help deliver the world’s first prescription meditation app by developing trial protocol and data collection forms, establishing and maintaining relationships with clinical site staff and/or study subjects, monitoring data to ensure quality data collection and managing overall clinical execution. This position will work with internal staff members (e.g. Engineering, Regulatory, Quality, etc.) and external consultants to assure high quality data collection and successful project delivery.

How your skills and passion will come to life at Headspace:

• Execute clinical studies and guide the achievement of all project deliverables with little to no supervision
• Develop or provide input into the required clinical documents (e.g. the protocol, study budget and project schedule, study training materials, study reports, monitoring plans, etc.) in collaboration with investigators and the cross-functional study team
• Manage clinical sites, including document collection, site qualification/ initiation/close-out visits and correspondence 
• Monitor site files to ensure audit readiness (in accordance with local clinical regulations) and closely tracks clinical data quality
• Critically evaluate study progress and metrics. Collaborates with manager and cross-functional team to identify risks and create mitigation plans
• Partner with key functional areas in order to align the clinical study with needs for other cross-functional team members (Marketing, Regulatory, Engineering, etc.)
• Assist with data entry, analysis and overall interpretation of clinical data
• Assist with the creation of clinical procedures and process improvement initiatives

• Cultivate strong relationship with clinical investigators, site staff and study subjects

What you’ve accomplished:

• B.S. degree from an accredited college or university. Graduate degree is preferred
• 5-8 years of professional level clinical experience, preferably in a medical device or pharmaceutical environment.
• Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical studies

• Proficiency in clinical regulations (FDA, GLP, MedDev) and processes associated with conducting a clinical study
• Strong customer-facing skills with a proven ability to identify customer requirements and manage expectations
• Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing

• Demonstrated ability to identify and adapt to shifting priorities and competing demands
and maintain composure in difficult circumstances
• High attention to detail and accuracy
• Willingness to be a team player wearing many hats and willing to jump in when needed
• Proficient knowledge of medical terminology, clinical practices, physiology and/or applicable disease states and project management

How to get started:

If you’re excited by the idea of seeing yourself in this role at Headspace, please apply with your CV and a cover letter that best expresses your interest and unique qualifications.