About this role
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!
*SUMMARY: Applies both business knowledge and technical expertise to support the implementation of clinical systems for business stakeholders to meet cross-organizational business needs as well as the configuration of systems to meet study requirements by providing analysis, **recommendation, documentation, and delivery of technical solutions. *
*RESPONSIBILITIES:*
_Tasks may include but are not limited to:_
Provide technical input to multi-disciplined project teams tasked by senior executives to address particular business needs during all project phases from discovery to retirement
Provide analysis input, technical documentation, and other support needed to build a business case for strategic initiatives supporting departments across the corporation
Apply both business as well as technical expertise to assist in the selection and implementation of external systems and services
Provide technical support to drive adoption of new solutions
Produce and maintain business requirement, configuration requirement, and technical specification documentation for clinical systems as well as for study-specific software implementations or configurations, such as IRT or cross-system integrations
Elicit stakeholders underlying business needs and transform them into documented business requirements, via multiple and various techniques including: interviewing stakeholders and users, applying business knowledge and insight, researching industry best practices and emerging technology, and considering options beyond stakeholders suggested solutions
Manage the requirements change process to ensure traceability and in alignment with departmental processes and tools
Ensure effective communication of business and functional requirements to the project team and stakeholders
Provide expertise and mentorship to the project team and stakeholders in the use of new systems
Configure systems and integrations between systems to meet the needs of documented requirements at a system or study level, in alignment with relevant SOPs and work practices
Provide quality control review of configurations implemented by others to verify alignment with SOPs and requirements
Support or execute the design, implementation, and quality control review of reports using business intelligence tools
Perform other duties as assigned
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
*OTHER SKILLS AND ABILITIES: *
Ability to communicate concisely and effectively in both written and spoken English
Proficient in the use of common office software
Highly effective in the use of interviews to uncover fundamental business requirements
Strong presentation skills
Able to work with all levels of stakeholders including senior executives
Ability to quickly become proficient in new systems, including the ability to represent system capabilities via demonstration
Self-motivated individual who can positively contribute to a team environment
High attention to detail
Highly creative, and able to adapt to new technologies, concepts and processes, and to make improvements and solve problems
Ability to mentor others in new technologies and best practices
*REQUIREMENTS:*
Educated to degree level in a relevant discipline or able to demonstrate equivalent work experience
Experience of analysing user or business requirements and documenting them
Experience with various modelling techniques such as process modeling, data modeling, system modeling
5+ years experience in the conduct of clinical trials and an understanding of the computer systems utilized in support of clinical trials OR in business systems analysis for medium to large back office systems
Understanding of application and integration infrastructures and how they can and should be utilized to achieve business goals
Familiarity with user experience concepts and best practices
Familiarity with risk assessment and mitigation planning strategies
Familiarity with GxP regulatory requirements
Understanding of IRT design and just-in-time drug supply desired
Familiarity with clinical trials, patient safety, data integrity and associated regulations desired
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
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 .