Clinical Study Manager

Role: Clinical Study Manager

Location: Mountain View, CA

Duration: 12 Months Contract

Client: Samsung Research America

Job Summary:

Seeking a Clinical Study Manager to assist with management of its Sponsored Research program. The ideal candidate is well versed in clinical study initiation/execution and has expertise in wearables and technical troubleshooting. This position will interact closely with the clinical site through assisting with study design, contracting, onboarding and study execution. This role also requires hands on technical proficiency to optimize deployment, monitoring and troubleshooting of mobile apps and wearable devices. Additionally, this person will collaborate with DHT’s multidisciplinary teams to enhance outcomes through wearable technology while maintaining compliance with regulatory and quality standards.

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:

Key Competencies:

• 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).

Qualifications:

• 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.
• Strong understanding of clinical workflows and regulatory standards (e.g., FDA, ICH-GCP, HIPAA).

Job Type: Contract

Pay: $95.00 - $102.00 per hour

Schedule:

• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• clinical management: 3 years (Required)
• mobile or wearable devices: 3 years (Required)
• clinical workflows: 3 years (Required)
• regulatory standards (e.g., FDA, ICH-GCP, HIPAA).: 3 years (Required)

License/Certification:

• Certified Clinical Research Professional (CCRP) (Preferred)
• CompTIA, Health IT Certification (Preferred)

Location:

• Mountain View, CA 94043 (Required)

Work Location: In person

Salary : $95 - $102