About the Role
Title: Project Manager, CPS
Location: Madison United States
Job Description:
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US.
We are currently seeking a Project Manager, to lead and support our Clinical Pharmacology Start-up team in initiating Early Phase clinical trials for our clients with maximum speed and efficiency.
This is a full-time, remote based position in the US.
WHAT YOU WILL DO
You will utilize your strong background in managing clinical trials, particularly in Phase 1 studies, across therapeutic areas such as oncology and impairments. Proficiency in Microsoft Project, CTMS, eTMF, and Medidata RAVE to manage clinical trial operations efficiently and effectively.
Other key responsibilities:
- Develop and manage detailed project timelines using Microsoft Project to ensure milestones are met.
- Oversee the clinical trial process with a solid understanding of CTMS to track study progress and deliverables.
- Manage trial documentation, ensuring compliance and quality through eTMF systems.
- Handle electronic data capture and database management using Medidata RAVE for accurate and efficient data collection.
- Provide project leadership and support in Phase 1 clinical trials, with a focus on patients with impairments, including those within oncology therapeutic areas.
- Collaborate with cross-functional teams to ensure adherence to regulatory standards, timelines, and budgets.
- Ensure trial operations comply with GCP, SOPs, and other regulatory requirements.
- Ability to travel 10-20% in the US and UK.
- All other duties as needed or assigned.
YOU NEED TO BRING…
- University/college degree (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution.
- In lieu of the above requirement, candidates with a 2-year Associate Degree and additional 5 or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Minimum of 5 years’ relevant clinical research experience in a pharmaceutical company/CRO including demonstrated skills and competency in project management tasks.
- 4 years’ experience of impairment or patient care required.
Working knowledge of ICH guidelines, GCP, and international regulatory requirements for clinical development programs.