04 Aug
|
TFS HealthScience
|
New South Wales
04 Aug
TFS HealthScience
New South Wales
TFS HealthScience is a global, mid-sized Contract
Research Organization (CRO) dedicated to supporting biotechnology
and pharmaceutical companies throughout their clinical development
journey. We provide full-service capabilities, resourcing, and
Functional Service Provider (FSP) solutions to help bring
innovative therapies to patients worldwide. We are currently
seeking a Senior Clinical Research Associate (SCRA) with strong
ophthalmology experience . This role involves working with a key
sponsor on Phase III ophthalmology studies, ensuring high quality
study execution, regulatory compliance, and effective site
management across the full monitoring lifecycle. Key
Responsibilities: Lead site monitoring activities for ophthalmology
trials, ensuring adherence to protocol, GCP, and regulatory
requirements. Implement risk-based approaches to ensure proactive
issue resolution and maintain trial quality. Manage ethics
committee submissions, amendments, and periodic regulatory
reporting, including safety event notifications. Contribute to site
activation, including Site Initiation Visits (SIVs) and
investigator training. Ensure proper trial documentation, monitor
data integrity, and support study closeout. Qualifications: Prior
experience in clinical trial monitoring within a CRO, biotech, or
pharmaceutical company. At least 1 year of therapeutic expertise in
ophthalmology trials.
Familiarity with local and international
regulatory requirements. Strong interpersonal skills to engage
effectively with sponsors and site staff. Join us in driving
forward cutting-edge clinical research in ophthalmology and beyond.
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 700 professionals, TFS
delivers tailored clinical research services in more than 40
countries with adaptable 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.
📌 Senior Clinical Research Associate (New South Wales)
🏢 TFS HealthScience
📍 New South Wales