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 Disease area- team you will working alongside
passionate and innovative professionals to ensure our customers
achieve their goals. The Study Start Up Lead is 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 skilled 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.

📌 Study Start Up Lead (New South Wales)
🏢 TFS HealthScience
📍 New South Wales