Associate Director, Clinical Data Standards

Associate Director, Clinical Data Standards

SDTM SME

UK or EU home based

This is a Senior Leadership position in which you will be managing a team of Clinical Standards SDTM experts and supporting global Clinical Data Standards strategy

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Responsibilities:

• Defines and implements core ICON, sponsor, and therapeutic area standards for the purpose of increasing efficiency, productivity and quality of deliverables of SDTM standards.

• Provides data standards expertise to study teams to ensure efficient compliance with data standards and regulatory submission requirements

• Uses influence and skills to effectively build relationships across the global organization in support of the standards vision and communicates development activities and standards metrics

• Responsible for the implementation, strategy, and configuration of metadata used to manage libraries of CDISC related metadata, terminology and related standards.

• Manages Clinical Standards SDTM experts: creation & evolution of the data standards strategy, resource allocation and work prioritization, professional development and mentoring for Clinical Data Standards team members

To be successful, you will need:

• BS/BA or MS in a life science or analytical area

• 10+ years relevant experience

• Has either directly managed direct reports or lead project teams in a matrix environment

• Proven track record for development and management of a standards library.

• In-depth knowledge of data management systems and processes, analysis and reporting principles.

• Advanced knowledge of clinical programming aspects of clinical research, data management, standards compliance methodologies, metadata management and data analysis

• Advanced knowledge of all CDISC guidance documents and implementation guides, as well as FDA, EMA and PMDA guidance and regulations regarding electronic submission of data

• Excellent written and oral communication skills, with demonstrated leadership ability

• Advanced ability to work with management in the development and collection of metrics

• Advanced ability to collaborate with sponsors on standards implementations

• Demonstrated expertise in multiple functional area standards or multiple CDISC standards

• Demonstrated ability to plan, supervise, implement and monitor standards governance processes

• Demonstrated successful client interactions in library management of client-specific standards, business development and consultancy with internal and external clients

• Previous experience using computerized information systems; experience with PC Windows and word processing

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 through the form below.

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