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Global drug and device development services

Senior Clinical System Lead - Full Service IOD Clinical Data Science

Clinical Research OperationsUpdated on Nov 11
Full-time

About the Job

Requirements

  • At least five years of clinical data management experience, including implementation and management of clinical data systems.
  • Technical understanding of relational databases and the ability to create medium- to complex-level data flow diagrams.
  • Applied project management skills, including forecasting timelines and resource requirements and tracking finances.
  • Detailed understanding of protocol content and interpretation of data collection requirements, considering both user experience and underlying dataset structures.
  • Ability to lead internal user acceptance testing of configured system solutions.
  • Bachelor’s degree or local equivalent; an equivalent combination of education, training, and relevant experience may be considered in place of the stated education and experience.
  • Fluent English and the host country language, in reading, writing, and speaking.
  • Legal right to work in the country where the role is based.

Responsibilities

  • Support sales efforts by providing expertise to Business Development and assisting with and presenting at Bid Defense meetings.
  • Perform peer reviews of study-team technical documentation and work output.
  • Serve as a contact point for internal and external customer teams on assigned studies.
  • Assist in leading internal and external project kickoff meetings.
  • Perform quality-control peer reviews of case report forms.
  • Track issues that could affect project target dates, scope, or budget; keep functional management and project-management stakeholders informed and escalate potential problems.
  • Work independently and with other project leads to negotiate timelines and key deliverables with clients, external customers, and departments.
  • Contribute to oversight and management of system-integration setup and vendor interactions as needed.
  • Provide input to the Clinical Data Science Project Manager on actual and forecast units and hours for revenue and resources, and understand project-level revenue-recognition and forecasting processes.
  • Travel approximately 15% domestically and/or internationally.

Desired Qualifications

  • Ability to react quickly and adapt to changing requirements, processes, and timelines in an agile manner.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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