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.

W hat a Associate Clinical Systems Project Manager does at Worldwide

Manages the successful continued delivery of assigned live clinical systems projects by ensuring high quality execution and work products and by meeting the established project budget and schedule

What you will do

• Proactively identify the incidence of additional scope and work with stakeholders to determine the appropriate course of action, raising change orders as needed
• Plan project amendment scope and timelines to ensure successful delivery by ensuring the availability of all necessary participants, and by identifying risks and corresponding mitigation plans
• Provide oversight and accountability of deliverables, ensuring they meet Worldwide SOP’s, current Good Clinical Practice (GCP) and other applicable regulations
• Liaise with staff and management as applicable to manage project budgets
• When applicable, ensure that vendor contracts, budgets, schedules, and deliverables align with the project needs
• Continuously assess project status, re-assess and revise risks, oversee issue documentation and escalation, and ensure the project team and stakeholders remain informed of project status, risks, and issues throughout the project (including both periodic project health updates as well as ad hoc communications for emerging impacts)
• Upon notification of protocol amendment collaborate with functional leads to identify, evaluate, and communicate project requirements, assign and revise assignment of resources, to interpret and resolve project issues, and to ensure all project objectives and work products are completed
• Coordinate or execute resourcing change and task progress updates to the project resource management system
• Coordinate and lead well-organized project meetings, and ensure minutes and action items are distributed
• Review and provide approval for updates to project documents authored by other project team members or vendors, ensuring alignment with project objectives, Worldwide SOPs, and regulatory requirements
• Ensure all project documentation is filed timely, is complete and accurate, and is signed as appropriate
• Coordinate and ensure completion of user acceptance testing for system amendments by appropriate stakeholders as required
• Coordinate installation and operational qualification of amendments where applicable
• Request, receive and process/upload draft and final subject and kit schedules and inventory release files where required for projects that include study RTSM delivery
• Provide oversight and support of assigned ongoing studies, including periodic on-call support when required
• Coordinate the identification, documentation, and management of incidents that occur both within as well as outside of project delivery
• Fully cooperate with auditors or regulatory authority inspectors before, during and after projects as applicable
• Contribute to the identification and implementation of process improvement initiatives

What you will bring to the role

• Ability to communicate concisely and effectively in both written and spoken English
• Proficient client-facing skills
• Proficient in the use of common office software
• Self-motivated individual who can positively contribute to a team environment
• High attention to detail
• Ability to prioritize and handle multiple projects simultaneously
• Flexible and able to use sound independent judgment and take initiative to assess information
• Able to make effective decisions in a fast-paced, highly dynamic environment

Your experience

• Educated to degree level in a relevant discipline or able to demonstrate equivalent experience
• Minimum of 2 years experience within CRO /pharma/scientific environment
• Experience working in regulated environments such as clinical trials (GAMP, ISO Standards)
• Understanding of clinical trials, blinding, patient safety, data integrity and associated regulations

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!

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