Clinical Study Manager (Project Manager)
Remote (Preference if located in AZ, CA, CO, FL, GA, MA, MD, NC, NH, NJ, NV, OH, OR, PA, TN, TX)
About VivoSense
VivoSense is a science and technology company specializing in digital health technologies (DHTs) including wearable sensors, mobile applications, and connected monitoring tools. We partner with pharmaceutical sponsors, healthcare providers, and academic groups to develop and deliver realworld digital clinical measures backed by rigorous scientific and analytic expertise.
Following our Series A financing in 2022, we are expanding our digital biomarker and clinical operations capabilities. We are seeking a Clinical Study Manager (CSM) to support our growing portfolio of DHTenabled clinical trials as we continue building more structured, CRO-aligned processes.
About the Role
The CSM oversees daytoday management of clinical studies, coordinating timelines, vendors, documentation, and communication to ensure quality and compliant delivery. This role blends traditional clinical study operations with the dynamic environment of digital health, requiring adaptability and strong crossfunctional partnership.
Because our digital endpoints depend heavily on scientific and data workflows, this role involves daily collaboration with science, data, engineering, and operational teams to ensure alignment between scientific intent, data pipelines, and execution.
Key Responsibilities
Study Leadership & Oversight
- Serve as the operational point of contact across internal teams, sponsors, vendors, and sites.
- Lead and coordinatecrossfunctionalstudy teams, driving clarity, alignment, andfollowthrough.
- Work closely with scientific and technical teams to ensure study execution supports digital endpoint requirements.
- Contribute to operational refinement as processes continue to mature.
Study Planning & Execution
- Partnerwith scientific and data leads todevelopandrefinestudy plans.
- Oversee startup activities including vendor onboarding, site readiness, training materials, and regulatory documentation.
- Ensure readiness and feasibility of DHT components, including device provisioning, validation, and data flow planning.
- Apply clinical rigor while supporting innovation in digital endpoint workflows.
Study Monitoring & Quality
- Track study progress against timelines, budgets, KPIs, and data quality metrics.
- Maintain anauditreadyTMF and support compliance with GCP and SOPs.
- Identifyissues related to sites, vendors, technology, or data and supporttimelyresolution.
Vendor, Site, and Client Management
- Managethirdpartyvendors to ensure delivery against scope and quality expectations.
- Support study sites with clear operational guidance and ongoing communications.
- Provide structured updates to sponsors, including risks, decisions, and mitigations.
Data & Deliverable Management
- Collaborate with data management, data science, engineering, and scientific teams to ensure smooth data collection and transfer.
- Support delivery of key project outputs such as datasets, digital endpoint reports, dashboards, and status summaries.
Culture & Collaboration
- Contribute to a collaborative,sciencedriventeamculture.
- Embrace evolving processes and help build operational maturity.
Qualifications
Required
- Bachelor’s degree in a scientific, technical, orhealthrelatedfield.
- 2–5 years of clinical study or project management experience.
- Strong grounding in GCP, clinical trial operations, site/vendor oversight, and study documentation.
- Ability to work independently in evolving environments and collaborate across disciplines.
- Excellent communication, organization, andproblemsolvingskills.
- Proficiencywith Microsoft tools and project management systems.
- Experience in clinical research preferred; candidates from adjacent fields considered if they can apply their skills in a regulated environment.
Preferred
- Experience with digital health technologies or wearable sensors.
- Familiarity with digital endpoint development or DHT data workflows.
- PMP/CAPM or similar certification.
- Experience in a startup or rapidly growing organization.
Benefits
(Condensed but still comprehensive)
- Unlimited PTO • Stock Options • Annual Bonus
- Health, Dental, Vision • Life Insurance
- 401K with Safe Harbor Contribution
- Professional Development Opportunities
- Remote Work & Flexible Hours
- Collaborative,missiondriven team environment
Salary range - DOE
$85,000 - $100,000 based on candidate professional experience and geographical region.