Clinical Study Manager

VivoSense: Clinical Study Manager

Remote - USA (preference if located in CA, CO, FL, GA, MA, MD, NC, NJ, NV NY, OH, OR, TX)

About VivoSense

Since 2010 VivoSense has been the premier science and technology company delivering end-to-end services and solutions for clients collecting clinical data from digital health technologies (DHTs), such as wearable sensors, mobile applications, and connected health monitoring tools. Working with drug developers, healthcare providers and academics, VivoSense develops and validates real-world digital clinical measures that matter to patients, and provides advanced software, analytics, and scientific expertise to improve the quality, accuracy, timeliness and ease of data analysis and insight generation from complex DHT data.

In 2022, VivoSense secured Series A financing and we are growing our team as we evolve our software platform, establish R&D capabilities and expand our client-facing business. We are seeking a talented and motivated individual to join our science operations team to bring expertise and the highest levels of quality to our client partnerships.

About the role

You will join a small, ambitious, cross-functional team, focused on providing an end-to-end service for external client sponsors. This is a multi-faceted role in which you will have the opportunity to lead the scientific offering on client projects including 1) driving all phases of digital evidence generation, from gathering patient input and performing landscape reviews, to leading study conceptualization, design, and insight delivery, and 2) working closely with project management, data analysis, and software teams to oversee and execute on client defined projects. Projects will be diverse but will focus broadly on the development and implementation of novel forms of digital evidence in clinical trials and will cover a range of therapeutic areas, stakeholder groups and patient journeys.

Competitive candidates will have a broad background in human subjects' research, be able to work both independently and cross-functionally, have strong written and oral communication skills, and have a passion for improving patient outcomes through novel digital health technologies.

Responsibilities:

• LEADING: Lead global clinical trials from initiation to completion, overseeing study activities including data collection, compliance reporting, analysis, and device supply procurement, while ensuring regulatory compliance throughout, including adherence to ICH GCP, regulatory requirements, and consistency with the study protocol.
• INITIATION AND PLANNING: Develop study specific plans and clinical documents such as but not limited to project management plans, vendor management plans, and data management plans, data transfer specifications, data analysis plans, and data quality and compliance plans.
• MANAGING AND EXECUTING: Oversee the implementation of all planned activities, ensuring adherence to scope, timelines, budgets, and regulatory requirements, while also coordinating resources effectively to achieve milestones and deliverables within the project lifecycle. This process involves constant monitoring, problem-solving, and communication to address any deviations, mitigate risks, and maintain quality standards, ultimately aiming for successful completion and accurate data collection for analysis and delivery of final project deliverables.
• FOSTERING EXCELLENCE AND ORGANIZATIONAL GROWTH: Collaborative contributions to business development initiatives, ensuring effective budget change control measures, optimizing departmental procedures, and driving cross-functional process improvements to streamline operations and enhance overall organizational efficiency and effectiveness.
• CULTIVATING COMPANY CULTURE: Contribute to company culture within VivoSense, promoting knowledge sharing and bringing new ideas into the group.

Requirements/Qualifications:

• Bachelor’s degree in a relevant field.
• 3+ years of experience in clinical study management, preferably in the pharmaceutical industry.
• In-depth understanding of Good Clinical Practice (GCP) guidelines, relevant regulatory requirements (e.g., FDA, EMA), and industry standards for conducting clinical trials.
• Must occasionally travel to attend in-person company meetings as required.

Bonus Qualifications:

• Clinical research credentials such as ACRP-PM, CCRA, ACRP-CP are desirable.
• Project management credentials such as PMP, ACRP-PM, CAPM, PMI-ACP are desirable.

If you have the qualifications and passion for leading innovative clinical research studies in a dynamic environment, we encourage you to apply for this exciting opportunity.

Additional benefits and perks:  

• Unlimited PTO 
• Board approved stock options 
• Board approved annual bonus 
• Direct access to senior leadership 
• Healthcare 
• Vision/Dental 
• Life Insurance 
• Professional growth training 
• 401K with Safeharbor employer contribution 
• Remote work 
• Flexible working hours 
• Amazing culture and team to work with 

Salary range - DOE  

$90,000 - $120,000 based on candidate professional experience and geographical region.  

Further information  

Find out more about our science:  

• Digital measure evaluation, acceptance and qualification (https://www.karger.com/Article/FullText/514730 ) 
• Validation of gait speed measures (https://mhealth.jmir.org/2019/11/e15191/ ) 
• Measures that matter (https://www.karger.com/Article/FullText/509725) 
• Our CSO Kate Lyden talks about digital measures (https://www.youtube.com/watch?v=9Z8IJh5SWtk)