The Digital Health Team (DHT) of a leading global device company is looking for a Clinical Study Manager to support the management of its Sponsored Research program. The ideal candidate will have strong experience in clinical study initiation and execution, along with expertise in wearables and technical troubleshooting. In this role, you will work closely with clinical sites to assist with study design, contracting, onboarding, and overall study execution. A key aspect of the position is hands-on technical proficiency, optimizing the deployment, monitoring, and troubleshooting of mobile apps and wearable devices. You’ll also collaborate with DHT’s multidisciplinary teams to drive outcomes through wearable technology while ensuring compliance with regulatory and quality standards. If you’re passionate about advancing digital health and want to be part of a dynamic and innovative team, we encourage you to apply!

Key Responsibilities:

Project Planning and Clinical Execution:

Develop and manage project plans, timelines, and deliverables for clinical trials or research initiatives, ideally in a healthcare setting.
Define project objectives, scope, and resources in collaboration with stakeholders.
Conduct clinical site training related to Samsung products (phone, watch, ring, tablet), as well as user guides and patient facing material.

Technology Implementation and Management:

Partner with software and R&D team to understand Samsung’s research capabilities and design data collection that meets the requirements of the protocol.
Oversee the deployment, integration, and optimization of wearable devices in clinical workflows or research projects.
Develop protocols, guidelines and user manuals for wearable device usage, data collection, and patient education.
Perform extensive testing on all research app builds and ensure they work in accordance with each site’s clinical processes.
Dry run protocols/user guides to ensure accuracy of design.

Technical Troubleshooting and Support:

Serve as the point of contact for wearable device technical issues, resolving problems efficiently to minimize disruptions.
Collaborate with technical teams, vendors, and manufacturers to address complex issues and implement device updates.
Conduct testing and validation of devices to ensure accuracy and functionality.
Partner with SRA team to troubleshoot any issues in the field.

Collaboration and Communication:

Work with cross-functional teams, including R&D, software, biomarkers, UX/UI, clinical operations, and researchers, to ensure seamless integration of wearable technologies.
Act as a liaison between stakeholders to communicate technical and clinical needs effectively.

Compliance and Quality Assurance:

Ensure wearable device usage complies with regulatory requirements, industry standards, and institutional policies.
Maintain comprehensive documentation related to device troubleshooting and performance.

Skills:

Technical proficiency in mobile or wearable device operations and integration.
Excellent problem-solving, critical thinking, and organizational skills.
Strong communication skills to collaborate across technical and clinical teams.
Ability to manage multiple priorities in a fast-paced, evolving environment.

Preferred Certifications:

Certified Clinical Research Professional (CCRP) or similar clinical certification.
Technical certifications relevant to wearable devices or healthcare IT (e.g., CompTIA, Health IT Certification).

Education:

Bachelor’s degree in nursing, biomedical engineering, healthcare management, or a related field (Master’s preferred).
3+ years of experience in clinical management.
Hands-on experience with mobile or wearable devices, including troubleshooting and technical support.
Understanding of clinical workflows and regulatory standards (e.g., FDA, ICH-GCP, HIPAA).

Type: Contract

Duration: 12 months

Location: On-site or hybrid (Mountain View, CA)

Pay Rate Range: $86.00 - $102.00 p/h

OSI Engineering jobs

Clinical Trial Manager