We recognize that Project Management is the bedrock of a successful clinical study. An outstanding Project Management team over-communicates with the sponsors team, keeping them informed of every detail, positive and otherwise.
QUINTESSENTIAL takes a team approach to project management. Each team is comprised on a highly dedicated interdisciplinary team led by one Project Manager who is the lead point-of-contact throughout the study.
We have an outstanding track record of continuity in our project management teams, which significantly facilitates communication with the sponsor's study team.
At QUINTESSENTIAL,our project managers have proven expertise in clinical and late stage research.
Our project managers:
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Serve as a primary resource and point of communication for the clients and project teams
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Provide direction and leadership to the project teams, including specifications for quality, time and cost of deliverables
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Utilize capabilities, systems and processes to assure efficiency and accuracy throughout the project
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Follows industry risk management process, addressing potential obstacles that may impact study timelines and / or quality.
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Maintains a flexible, can-do approach to address issues proactively and innovatively
Project managers have several years of experience in clinical research, select therapy area, and specific needs of biotech, devices, generics and pharmaceutical sponsors. They possess managerial capabilities to work with investigators, IRB/IECs, site personnel, sponsor teams, vendors and subcontractors. Project managers are also trained in ‘soft skills’ for effective interpersonal relationships. They are familiar with aligning site and CRO trial management systems to sponsor requirements.