Clinical Systems Lead - UK/Serbia/LATAM - Remote
Job Description
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 over 3,500+ 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.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What the Clincal Systems Department does at Worldwide
Our Clinical Systems Department plays an essential role for the entire organization by ensuring our systems are developed to study specifications, fully integrated, optimally running, and well-maintained throughout the studies’ lifecycle. The department works closely with industry specific systems such as: IRT, RTSM, EDC, RBQM Opra, ClinSpark, eTMF and CTMS. The department has various roles including client-facing Project Managers, System and Software Designers, and Implementation and Validation specialists. Each of these areas provides mentorship and training. In working with a variety of systems, the department has a proven record of success for promotions and growth internally.
What you will do
Act as the functional lead for delivery of one or more clinical system study implementations
Collaborating with the project manager to track and report project status
Leading the effort to deliver the necessary study configuration and documentation within schedule and to a high level of quality and completeness
Providing periodic demonstrations of system functionality to internal and client stakeholders, capturing and resolving issues and requests for change
Author clinical system User Requirements Specifications where required
Perform configuration and study setup to meet study timelines, fulfill business and technical requirements, and align with SOPs
Perform quality control checks and/or lead or participate in testing efforts for study builds (as required by the system’s SOPs) to ensure study build compliance with requirements and SOPS
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
Able to work independently or in a multi-disciplinary team
High attention to detail
Able to be creative, adapt to new technologies, concepts and processes, make improvements and solve problems
Your experience
Educated to degree level in a relevant discipline or be able to demonstrate equivalent experience
2+ years’ experience in a combination of Contract Research Organization (CRO) experience, CTMS or IRT study delivery, or clinical systems configuration desired
Experience working in regulated environments such as clinical trials (GAMP, ISO Standards)
Understanding of clinical trials, blinding, patient safety, data integrity and associated regulations
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.