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.
The important thing for us is you are comfortable working in an environment that is:
Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
Changing priorities constantly asking you to prioritize and adapt on the spot.
Teamwork and people skills are essential for the study to run smoothly.
Technology based. We collect our data directly into an electronic environment.
Pay Range: $100,000 - $120,000 USD
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here. Application Deadline: October 11, 2024.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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