SEND specialist

As Nonclinical SEND data associate - sponsor dedicated, you will provide technical expertise in the on-going development and maintenance of processes, initiatives and management of CDISC SEND data, in order to allow the non clinical submissions group to deliver on FDA regulatory requirements for non clinical data standards, as well as SEND data utilisation across the Sponsor, to maximise the opportunities this presents for Industry.

What you will be doing

• Provide support across nonclinical functional areas to promote and enforce the use of non clinical data standards. Maintain metadata libraries, as adapted from industry standards

• Review and assess the impact of newly released and updated data standards and guidance documents to incorporate into the sponsor's business practices, as applicable

• Communicate Sponsor's data requirements to external vendors. Interact with external vendor personnel regarding standardized data transfer specifications, as necessary.
• Responsibility for quality validation and management of non clinical datasets. Communicating resolutions and managing timelines with external partners
• Provide training to internal customers and team members as appropriate.
• Assist in warehousing and visualisation activities that utilise SEND data within Sponsor
• Provide effective scheduling assistance in the timely delivery of SEND data for submissions
• Support transformation of in-house data into CDISC SEND format, ensuring submission ready datasets are produced
• Maintaining an in-depth understanding of evolving CDISC SEND standards and other regulatory standards/guidance
• Proactively manage own workload within timelines provided for FDA submissions
• Good clear communication skills both with management and project teams

You Are

• Knowledge of CDISC standards is essential.
• Understanding of non clinical study designs, data and documentation (e.g. plan/protocol, study schedules, deviations, drafts and final reports)
• Knowledge of regulatory guidelines and industry standards (FDA, ICH/GLP, PhUSE)
• Experience in data process builds
• Experience of LIMS and SEND solution software
• Education: Bachelor’s degree (B.A./B.S.) or equivalent in a scientific or related discipline.

Experience: Three to Five years related experience in a scientific environment. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above

Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.  In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.