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Data Systems Analyst Jobs

Company

ICON
Address , Remote
Employment type
Salary
Expires 2023-06-27
Posted at 1 year ago
Job Description
Ensure data acquired for the purpose of research (particularly regulatory and marketing claim substantiation, during clinical evaluations, studies, and trials) is high quality and in compliance with regulatory body standards. The function is part of Global Biostatistics and Data Management within Clinical and Medical Affairs.

Responsibilities:
  • Assist CDM Systems activities (EDC, Study Build, Database Programming).
  • Other Duties as assigned.
  • Contribute to database programming support activities for clinical programs in line with timely and accurate data integration.
  • Able to work independently.
  • Develop and implement strategy for the improvement of productivity and standardizing of study build and programming activities.
  • Provide input for annual vendor selection activities for all areas of responsibility.
  • Provide input for technical infrastructure of the clinical programming and EDC environments with IT; contribute to strategy for integration of systems, including DM systems (EDC, CTMS, Data Warehouse, etc.) and partner systems (CTMS, IVRS, Safety database, etc.).
  • The ability to travel up to 15% of time.
  • Ensure guidelines and specifications on validation procedures and data transfer procedures are followed. Maintain appropriate documentation surrounding maintenance or archiving clinical data and/or database programs.
  • Assist in developing, applying and promoting consistent standards through standard processes and SOPs.
  • Assist in directing communication and training activities for non-technical staff and partners.

Qualifications:
  • BS Degree in Medical or Life Science related field with 0-3 years of Clinical Data Management experience in the device / pharma industry.
  • Proven ability to take independent action to initiate process improvement, when needed.
  • Practical knowledge of ICH, FDA, and GCP regulations and guidelines.
  • Well organized, able to multitask and prioritize competing tasks.
  • Knowledge of lab / image data and other external data sources.
  • Proven ability to deliver on delegated work efficiently.
  • Solid time-management skills to meet deliverables commensurate with a fast-paced environment.
  • Strong scientific background and understanding of clinical trials, pharmaceutical / device operations, and regulatory compliance.
  • Strong well-rounded technical skills: EDC, SAS, and CDISC.
  • Proven ability to work in a matrix-like manner where cross-functional interaction is implicit.
  • Able to manage expectations with supervisors, peers and customers. 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.