About the role
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.
Join Our Team as a Study Start Up Lead in Australia (home based)
- 1 FTE for next 3 months, then 0.2 FTE for additional 3 months -
About this role
As part of our CDS -Dermatology, Inmunology, Internal Diseasearea- team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.
The Study Start Up Leadis responsible for coordination and overview of startup activities from projects are awarded till last participant site is activated, ensuring the startup deliverables and timelines are achieved.
The Study start up lead will work 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.
May 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. This case will ensure all assigned SSU Specialist are adequately trained on project specific systems and procedures.
Develop and maintain Startup plan and timelines for their projects and track progress ensuring project deliverables and milestones are reached.
May manage the resource allocation of Start Up team on the project, in collaboration with respective line managers.
Responsible of coordinating EC/IRB submissions or any other notification requested as well as coordination with Regulatory department regarding HA/CA submissions/notification.
Ensure and oversight the proper aadaptation of Subject Information and Informed Consent documents according to local law and requirements.
Together with the Legal Department, coordinate the Clinical trial Agreements negotiation supporting the SSU Specialists and CRAs on handling the negotiation properly and on time.
Coordinate site evaluation and feasibility process for assigned projects.
Ensure all Start Up documentation is submitted properly and on time to the Trial master File.
Assist the Project Manager ensuring the Project is properly set up in CTMS and all information related to start up activities is properly updated.
Support the Project Manager coordinating the greenlight and site activations process and ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized, and specific project deliverables are completed.
Measure and evaluate project startup deliverables and metrics.
Update the Project Manager with status of start-up progress and ensure a proper escalation of any issue detected.
Qualifications:
Bachelor’s Degree, preferably in life science or nursing; or equivalent.
Minimum 4 years of experience in any relevant Clinical Operations experience related to Start Up procedures.
Able to work in a fast-paced environment with changing priorities.
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.
Ability to work independently as well as in a team matrix organization and multiple projects.
Excellent written and verbal communication skills as well as computer skills.
Excellent organizational and Line Management skills.
Ability and willingness to travel up to 10-20%
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 30 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 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.
Our core 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.
Originally posted on Himalayas