Data Manager/Standards

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 organisations. With our patients at the centre 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. The GCDS Data Standards Specialist II is a subject matter expert in implementation and maintenance of clinical data standards. The Data Standards Specialist is responsible for: Defining standard collection and mapping data definitions aligned with industry (CDISC) standards and Health Authority regulations Ensuring the definitions are maintained and aligned across the clinical lifecycle (e.g., data collection, analysis & report, and submission) deliverables Supporting the definition of maintenance of additional standards library components Participates in standards data governance reviews The GCDS Data Standards Specialist may contribute to the definition and maintenance of business processes related to the definition, use, maintenance and sharing of clinical data standards Support department initiatives and participate in cross-functional working groups and process improvement activities Participate in cross-functional project teams; establish collaborations/interactions with colleagues outside the department and makes frequent contacts external to the area and/or company Maintain knowledge of new technologies, industry standards, regulatory requirements, and Merck guidelines and SOPs. Able to work independently or as a team member with equal effectiveness. Interacts with staff across multiple Merck sites May mentor, guide, and / or train others in the implementation of clinical data standard models May support any other project or perform any other data management task deemed appropriate by management Education Minimum Requirement: Education: A. or B.S. degree, preferably in life sciences, computer science, or related discipline. Experience: 8 years work experience which includes 4 years of data management experience and a minimum 2 years in clinical data standards development; or advanced degree with 6 years work experience of which 2 years need to be in clinical data standards development. Required Experience and Skills: Advanced knowledge of clinical data standards development and implementation CDISC SDTM expertise: In-depth knowledge of and experience with applying the CDISC Study Data Tabulation Model (SDTM) A broad comprehensive knowledge of the clinical trial process including data management (data collection, processing, storage, and retrieval) and worldwide regulatory data management and reporting requirements. Strong knowledge of the Drug Discovery Process, ICH and GCP guidelines Knowledge of Analysis & Reporting Exceptional communication (oral and written) skills Must have an innovative spirit, outstanding interpersonal skills, and demonstrated proficiency in time management (ability to prioritize & manage multiple projects) . Preferred Experience and Skills: Electronic Data Capture expertise (e.g., InForm) Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. Thats 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.