Study Start up Lead
2 weeks ago
Join Our Team as a Study Start Up Lead
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
About this role
As part of our Study Start Up team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.
The Study Start Up Lead is responsible for the coordination and overview of the startup activities in accordance with company policies, SOPs, regulatory requirements in addition to financial and contractual obligations. The Study start up lead will plan and pro-actively coordinate, together with the study PM, the study startup activities to ensure key milestones are achieved and start up is performed within budget, on
schedule and in compliance with the appropriate - quality standards.
Key Responsibilities:
- Ensure all startup activities for projects are performed on-time, within the scope and budget and in compliance with ICH/GCP guidelines, SOPs and protocol requirements
- Together with the study Project Manager, manages the strategic aspects of projects startup and mitigating any risk setting up the proper action plan.
- Oversight and coordinate SSU Specialists, assigned to their programs being the initial point of contact and supporting them with startup activities and investigative sites liaison.
- Develop and maintain Startup plan and timelines for their projects and track progress ensuring project deliverables and milestones are reached.
- Ensure all SSU Specialists are adequately trained on project specific systems and
procedures. - Manage the resource allocation of Start Up team on the project, in collaboration with respective line managers (Directors Site Management)
Qualifications:
- Bachelor’s Degree, preferably in life science or nursing; or equivalent
- Minimum 3 years of experience as CRA including relevant on-site monitoring experience or any other relevant Clinical Operations experience related to Start Up procedures
- Able to work in a fast paced environment with changing prioritie
- Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas
- Possess the understanding of Good Clinical Practice regulations, ICH guidelines
What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
A Bit More About Us
Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our cores values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.
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