Study Start up Lead

Join Our Team as aStudy Start Up Lead

TFS HealthScience is a leading global midsize Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full servicecapabilities resourcing and Functional Service (FSP) solutions.

About this role

As part of our Study Start Upteam 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 proactively coordinate together with the study PM the studystartup 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 ontime within the scope and budgetand in compliance with ICH/GCP guidelines SOPs and protocol requirements
• Together with the study Project Manager manages the strategic aspects of projects startupand mitigating any risk setting up the proper action plan.
• Oversight and coordinate SSU Specialists assigned to their programs being the initial pointof contact and supporting them with startup activities and investigative sites liaison.
  
• Develop and maintain Startup plan and timelines for their projects and track progressensuring 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 withrespective line managers (Directors Site Management)

Qualifications: (Max 56)

• Bachelors Degree preferably in life science or nursing; or equivalent
• Minimum 3 years of experience as CRA including relevant onsite monitoring experience orany 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 drugsand 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. Youll 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 fullservice global Contract Research Organization (CRO) we build solutiondriven 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 decisionmaking 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.