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Jobs or company...

Clinical Study Manager

Salary undisclosed
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TITLE: Clinical Study Manager

POSITION TYPE: Full Time (W2)

LOCATION: Mountain View, CA

ABOUT WorldLink:

WorldLink is a rapidly growing information technology company at the forefront of the tech transformation. From custom software development to cloud hosting, from big data to cognitive computing, we help companies harness and leverage today’s most cutting-edge digital technologies to create value and grow.

Collaborative. Respectful. Work hard Play hard. A place to dream and do. These are just a few words that describe what life is like at WorldLink. We embrace a culture of experimentation and constantly strive for improvement and learning.

We take pride in our employees and their future with continued growth and career advancement. We put TEAM first. We are a competitive group that like to win. We're grounded by humility and driven by ambition. We're passionate, and we love tough problems and new challenges. You don't hear a lot of "I don't know how" or "I can't" at WorldLink. If you are passionate about what you do and having fun while doing it; tired of rigid and strict work environments and would like to work in a non-bureaucratic startup cultural environment, WorldLink may be the place for you.

For more information about our craft, visit https://worldlink-us.com .

WHO we’re looking for:

We are looking for a Clinical Study Manager who will be responsible, as part of the Digital Health Team, for assisting with management of the Sponsored Research program. The ideal candidate is well versed in clinical study initiation/execution and has expertise in wearables and technical troubleshooting. You will interact closely with the clinical site through assisting with study design, contracting, onboarding and study execution. You will also require hands-on technical proficiency to optimize deployment, monitoring and troubleshooting of mobile apps and wearable devices. Additionally, you will collaborate with DHT’s multidisciplinary teams to enhance outcomes through wearable technology while maintaining compliance with regulatory and quality standards.

Role and 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 brand 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 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 teams 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.

Required Experience and Education:

  • 3+ years of experience in clinical management.
  • Bachelor’s degree in nursing, biomedical engineering, healthcare management, or a related field (Master’s preferred).
  • (Preferred) Certified Clinical Research Professional (CCRP) or similar clinical certification.
  • (Preferred) Technical certifications relevant to wearable devices or healthcare IT (e.g., CompTIA, Health IT Certification).
  • 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).

Necessary Skills and Attributes:

  • Self-motivated individual with the ability to thrive in a team-based or independent environment.
  • Detail-oriented with strong organization skills.
  • Ability to work in a fast-paced environment.
  • Limited supervision and the exercise of discretion.
  • Technical proficiency in mobile or wearable device operations and integration.
  • Excellent problem-solving and critical thinking skills.
  • Strong communication skills to collaborate across technical and clinical teams.
  • Ability to manage multiple priorities in a fast-paced, evolving environment.