Lead Data Manager

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

TECHNICAL/COMMUNICATION SKILLS:
  • Displays sound project management skills and ability to prioritize workload
  • Demonstrates well-developed instincts and problem-solving skills in all areas of data management
  • In-depth knowledge of data management systems and processes, analysis and reporting principles
  • Excellent teamwork, organizational, interpersonal, conflict resolution, and problem-solving skills
  • Innovative
  • Comfortable with ambiguity
  • Excellent verbal and written communication skills
  • Works effectively with global teams in a diverse environment
PREFERRED EDUCATION, EXPERIENCE AND SKILLS: Prefer B.S. (or equivalent degree) in a scientific or allied health field and 4-6 years of relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background; Laboratory or sample management experience is a plusBenefits 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

Job Description As a Lead Clinical Data Manager (EDC Database) working on the Clinical Data Management team, you will lead EDC study builds, collaborating with the DM team and vendors. GENERAL POSITION SUMMARY:
  • Leads and manages the EDC study build life cycle for assigned studies, working with functional service provider (FSP) who programs databases
  • Ensures consistent use of standards and templates
  • Collaborates closely with study data manager for task coordination and information sharing
KEY RESPONSIBILITIES:
  • Develops specifications for eCRFs, edit checks, system configuration, and IXRS transfers
  • Plans, oversees, and participates in User Acceptance Testing. Creates UAT Plan, test scripts, and Summary Report
  • Maintains day-to-day contact with database programming staff to handle questions, troubleshoot, help resolve issues and mitigate risks
  • Partners with the data manager, medical coder, IXRS analyst, database programmers, and EDC access group to plan for success of study deliverables
  • Manages time-sensitive tasks around EDC go-live (coordinating the start of IXRS transfers, EDC access, availability of reports and database extracts)
  • Manages database amendments
  • Provides expert technical direction; assesses complex technical or procedural issues, chooses among alternatives and facilitates resolutions
  • Provides oversight to ensure deliverables adhere to Vertex and industry best practices, and to ensure high quality output is delivered in line with agreed timeline.
  • Keep EDC build timelines up to date
  • Performs other duties as assigned


United States-Remote