Clinical Study Manager (USA - REMOTE)
Clinical Study Manager (USA - REMOTE)
RemoteWorker US
San Diego, CA
See who RemoteWorker US has hired for this role
Job Description
Job Description
Clinical Study Manager
Remote (Preference if located in AZ, CA, CO, FL, GA, MA, MD, NC, NJ, NV NY, OH, OR, TN and 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:
Additional benefits and perks:
$90,000 - $120,000 based on candidate professional experience and geographical region.
Job Description
Clinical Study Manager
Remote (Preference if located in AZ, CA, CO, FL, GA, MA, MD, NC, NJ, NV NY, OH, OR, TN and 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.
- Bachelor’s degree in a relevant field.
- 3-7 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.
- 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.
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 Safe harbor employer contribution
- Remote work
- Flexible working hours
- Amazing culture and team to work with
$90,000 - $120,000 based on candidate professional experience and geographical region.
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Research, Analyst, and Information Technology -
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at RemoteWorker US by 2x
See who you knowGet notified about new Clinical Trial Manager jobs in San Diego, CA.
Sign in to create job alertSimilar jobs
People also viewed
-
Clinical Trial Manager
Clinical Trial Manager
-
Clinical Project Manager
Clinical Project Manager
-
Global Clinical Trial Manager Remote United States
Global Clinical Trial Manager Remote United States
-
Sr. Clinical Project Manager
Sr. Clinical Project Manager
-
Global Clinical Project Manager
Global Clinical Project Manager
-
Senior Clinical Trial Manager
Senior Clinical Trial Manager
-
Senior Global Clinical Project Manager - Vaccines
Senior Global Clinical Project Manager - Vaccines
-
Clinical Project Manager
Clinical Project Manager
-
Senior Local Clinical Trial Manager Remote United States
Senior Local Clinical Trial Manager Remote United States
-
Clinical Project Manager
Clinical Project Manager
Looking for a job?
Visit the Career Advice Hub to see tips on interviewing and resume writing.
View Career Advice Hub