We offer a full range of consulting, clinical development and commercialisation services from a global network of offices in 46 countries
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.
We are a global provider of co...
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The Senior Clinical Data Science Lead (Senior CDSL) serves as the primary contact for internal and external team members regarding clinical data science data review activities and leads these review activities to ensure delivery of data fit for analysis.
They are accountable for achieving clinical data science deliverables on-time, with high-quality, and to agreed financial metrics.
Develop and oversee timeliness of clinical data science activities during the life cycle of studies as it relates to data review and data delivery milestones
Provide input into clinical system development activities and clinical risk management activities
Track and keep functional management and those responsible for project management informed of any issues that might affect project target dates, scope or budget and escalates potential problems effectively and in a timely manner
Forecast budget, hours, and resourcing for clinical data review activities
Perform analytic review as defined in the scope of work and functional plans focusing on errors that matter or have a meaningful impact on the safety of the subject or interpretation of the final analysis
Accountable for the development of planning documents related to data review, data analytics, and data deliverables.
Participate in Sponsor and/or third-party audits.
Negotiate timelines and key deliverables with clients and/or external customers, vendors, and departments as needed
Travel (approximately 15%) domestic and/or international
TO BE SUCCESSFUL, YOU WILL NEED:
5+ years of clinical data management experience in a clinical research organization or pharmaceutical company
2+ years of experience working in a clinical research organization (CRO)
Experience as a functional lead of multiple low and moderately complex studies, whilst acting as a resource for less experienced colleagues
Experience with all steps within the data science lifecycle and most major data science study tasks, with proficiency in at least one Clinical Data Management system required (e.g., Medidata Rave, Inform, Oracle Clinical, Veeva)
Excellent communication skills
Budget and timeline management experience
Data Analytic and Data Validation experience
Bachelor’s degree or local equivalent
Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write, and speak fluent English and host country
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