Clinical Systems Project Associate

Who we are 

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. 

We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.  

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.    

What does the Clinical Systems Project Associate do at Worldwide 

The Clinical Systems Project Associate supports clinical systems and studies, and assists project managers, ensuring high quality execution of projects. Performs general administrative tasks.

What you will do  

• Work with and assist project managers on the development and support of clinical systems and studies
• Assist with the creation of project documents
• Assist with the development and maintenance of training courses
• Assist with the tracking of training as required for Worldwide, vendor, and study and site personnel
• Assist project managers with project communications, including the development of study status reports, meeting minutes and agendas and scheduling of calls
• Assist project managers with tracking deliverables and milestones, financial tracking, records retention and Trial Master File management
• Prepare support and helpdesk documentation
• Assist with User Acceptance Testing when required
• Perform quality checks on validation documentation
• Provide first-line and second-line support where appropriate to clinical systems supported by the Clinical Systems Department
• Respond to and resolve support requests, including monitoring and following up on outstanding support requests to meet Service Level Agreements
• Advise project manager of any ongoing or repeat support issues
• Make data updates directly in clinical systems in alignment with SOPs relevant for that system
• Perform database edits, drug management tasks, and other support accurately and efficiently to ensure the smooth operation of services and rapid issue resolution to meet SLAs
• Provide Quality Control checks on database edits, drug management tasks, and other support tasks that require checks for tasks completed by vendors or other Worldwide personnel
• Contribute to incident management
• Maintain and control access to various systems for both in-house and vendor systems
• Fully cooperate with auditors or regulatory authority inspectors before, during and after projects as applicable
• Participate in process and quality improvement efforts to increase overall operational efficiency
• Monitor study execution to ensure correct randomization and kit assignment function
• Ensure that all activities are appropriately documented and stored in accordance with the relevant SOP and requirements of the client company
• Perform other duties as assigned  

What you will bring to the role  

• A good standard of written and spoken English
• Proficient in the use of common office software
• Self-motivated individual who can positively contribute to a team environment
• Able to work independently or in a multi-disciplinary team
• High attention to detail
• Ability to prioritize and handle multiple projects simultaneously

Your experience 

• Educated to degree level in a relevant discipline or able to demonstrate equivalent experience
• 0-2 years experience within a clinical trial environment or pharma industry. 

Why Worldwide  

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.    

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!