Clinical Data Transfer Specialist (eSource)

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.

Qualifications

Required:
  • BS/BA degree, preferably in a health-related, life science or computer science area. MS degree plus 4 years of relevant experience is acceptable.
  • Minimum of 4 years data management, EDC/database programming and/or clinical development experience within the pharmaceutical/CRO industries.
  • Experience creating Data Transfer Agreements (DTAs) and/or Specifications.
  • Experience working with clinical study teams and vendors.
  • Experience working with multiple clinical data management systems including EDC.
  • Basic understanding of CDISC standards.
  • Knowledge of relational databases (e.g., Oracle-based systems, SAS).
  • Strong understanding of clinical trial documents (protocols, data management plans, CRFs, study reports) and processeses.
Preferred:
  • Rave experience
  • Oncology experience
  • Knowledge of FDA and ICH regulations, including 21 CFR Part 11 and FDA Guidance for Computerized Systems Used in Clinical Trials.
  • General knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.
  • Certified Clinical Data Manager (CCDM) certification (as administered by the Society for Clinical Data Management) or an equivalent professional certification.
  • EDC build certification (as administered by industry EDC software vendors).
GENERAL:To qualify for a role located in the U.S., applicants must be legally authorized to work in the United States and should not (now or in the future) require sponsorship for employment work visa status. 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.

Responsibilities

  • Define and develop the data collection and capture strategies to meet the requirements of U.S. or E.U.-based development programs.
  • Ensure timely setup and quality implementation of clinical study EDC designs and vendor data transfer deliverables from external sources to the customer.
  • Implement and enforce standards and technologies for the collection, validation and storage of clinical study data to maximize development program data integration.
  • Oversee external vendors who are providing data capture technologies and programming to achieve quality, timely, cost-effective study deliverables for studies run from the US or EU.
  • Represent the Clinical Data Systems function in support of assigned clinical studies led from the US or EU.
  • Propose study/program-level EDC and processing strategy, including technologies to meet the needs of the project team.
  • Define and manage the implementation of the global standards to the data collection and dataset deliverables, ensuring conformance to standards for assigned clinical studies. Standards include but are not limited to (e)CRF standards, database (SDTM) specifications, and metadata repository requirements.
  • Ensure all Clinical Systems Development study deliverables are completed in accordance with the requirements of the data management plan and all applicable customer standards.
  • Ensure all Clinical Systems Development study documentation has been appropriately filed in a timely manner.
  • Create and validate custom user reports from data capture reporting tools or data programming tools to facilitate the review of data by cross-functional team members.
  • Generate and quality assure subject electronic case report forms (CRFs) for use in clinical study reports, final study archival, and for archive at study sites.
  • Manage and report on progress of EDC and dataset deliverables, identify and resolve issues, work with the Data Manager to coordinate activities with the project team and management.
  • Anticipate and communicate resource and quality issues that may impact deliverables or timelines. Propose and implement solutions. Escalate issues to management as appropriate.
  • Contribute to the evaluation, selection and implementation of new clinical data integrity and technology processes, standards and technology solutions.
  • Comply with all applicable regulatory requirements and customer standards and procedures.


United States-Remote