About Fortrea
As a leading global contract research organization (CRO), Fortrea is committed to scientific rigor and has decades of clinical development experience. We offer a wide range of clinical development, patient access, and technology solutions to pharmaceutical, biotechnology, and medical device clients across more than 20 therapeutic areas. Operating in over 90 countries, we are transforming drug and device development for partners and patients worldwide.
Position Overview
Title: Study Manager
Location: Remote - USA
As the Study Manager, you will lead studies involving healthy volunteer and patient populations, managing complex protocols and client relationships. You will be accountable for all Data Management (DM) deliverables and will ensure that projects are executed according to established timelines and quality standards.
Project Accountability:
Oversee all DM deliverables, providing guidance to your DM study teams and reviewing their outputs to ensure the highest quality.
Compliance:
Ensure all projects adhere to relevant protocols, global SOPs, and GCP standards.
Collaboration:
Work with Project Managers or FSP Leads to build timelines and communicate effectively with multidisciplinary teams during study initiation.
Team Leadership:
Lead internal project team meetings, coordinate with EDC Design, SAS Programming, Statistics, and PK teams, and proactively identify and communicate risks.
Client Engagement:
Maintain strong client relationships, review satisfaction surveys, and implement action plans for process improvements and team training.
Resource Management:
Track scope changes, work with Project Managers to secure sponsor approval, and manage DM resources effectively.
Mentorship:
Provide leadership and coaching on DM processes and support performance evaluations for team members.
Continuous Learning:
Stay updated on new DM technologies and industry practices to drive process improvements.
Documentation:
Ensure accurate records of all work, perform reconciliation of clinical databases, and represent DM in new business opportunities.
Audits and Compliance:
Attend client or internal audits, resolving issues promptly and addressing client feedback.
Why Join Fortrea?
At Fortrea, we seek motivated problem-solvers and creative thinkers passionate about overcoming barriers in clinical trials. Our commitment is to revolutionize the development process, ensuring the swift delivery of life-changing therapies to patients. Join our exceptional team and enjoy a collaborative workspace that nurtures personal growth and enables you to make a meaningful global impact.
Equal Opportunity Employer
Fortrea is proud to be an Equal Opportunity Employer. We are committed to diversity and inclusion and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to protected characteristics. We encourage all qualified individuals to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.
Visit Fortrea's website for more details.
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