As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
The Global Trial Lead (GTL) is accountable and provides operational expertise for the successful cross-functional delivery of assigned global oncology clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements by taking an operational leadership role in a matrix organization.
The Global Trial Leader is accountable for oversight of external service providers, planning and execution of both internally managed and outsourced trials, with scope from draft protocol elements document to availability of the Clinical Study Report and applicable disclosure of the trial results.
This will include leading the cross-functional trial team and interfaces with all trial team members, building the trial operational plan, CRO management and budget and contracts management. You will ensure that the protocol feasibility and country and site selection process is conducted within the timelines and that the trial team has received the appropriate trial-specific training.
You will provide global operational leadership to the execution to plan and defines risk mitigation strategies and ensures implementation thereof.
You will hold a Bachelor’s Degree (or equivalent) preferably in Life Science and have a strong clinical research operational knowledge, project planning and management skills and experience within a pharmaceutical company and/or a CRO.
You will have proven strong experience managing or leading global or regional teams in a virtual environment and strong expertise in vendor management.
Excellent decision-making, analytical and strong financial management skills are essential to this position.
Minimum of 8-10 years clinical trial experience in the pharmaceutical industry or CRO - Required
Willingness and ability to travel up to 15-20% of the time, defined by business needs.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.