Clinical Data Standard Consultant

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

💼 Consultant

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Serve on Sponsor Standards and Technology Leadership teams. • Consult with clients on sponsor-specific CDISC centric implementation projects. • Participate in industry groups focused on the development of standards related initiatives (e.g. CDISC, PhUSE etc.). • Author, maintain, implement, and report status for Standards Related Project Plans. • Responsible for the implementation, strategy, and configuration of a metadata repository used to manage libraries of CDISC related metadata, terminology and related standards. • Mentor Clinical Data Standards Consultants. • Lead Subject Matter Expert teams on topics relevant to standards. • Identify areas for process improvement which may increase productivity, quality and / or compliance of deliverables in the areas from data collections through analysis and reporting. • Participate in the analysis of metrics and in creating recommendations to the management teams on process improvements together with the Director of Global Data Standards.

🎯 Requirements

• Minimum of 5 years of experience in industry in a role demonstrating knowledge of standards used by biometrics. • An undergraduate degree or international equivalent from an accredited institution • Demonstrated expertise in CDASH, SDTM standards and associated controlled terminology with a good understanding of CRF design concepts. • Excellent communication skills with demonstrated leadership ability.

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways