Data Management Trial Manager - Remote Based in US

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing:

As a Principal Lead Clinical Data Manager, you will oversee the data management strategy and project plans for collection and integration of all clinical data including but not limited to, case report forms (CRF) data, lab data, biomarker data, and patient reported outcomes for one or more trials within a specific drug program.  You will lead cross-functional, global teams to ensure all aspects of the project plan (from data management trial planning through submission components) are executed on time and with appropriate quality.  You will serve as a project manager for data management activities and represent global data management for assigned trials.

You are:

• Education: Bachelor’s degree preferred

  Experience:  7 years of data management experience preferred

  Skills:

  • Manage all operational aspects of clinical trials in compliance with GCP regulations, ICON policy and Client Company policy.
  • Manage project and timelines across Client programs and studies.
  • Ensure timeliness of deliverables for each phase of the study from study start-up through production and close-out activities.
  • Interact with various Data Management and other functional area colleagues, including, but not limited to: Biostatistics and Programming, Clinical, Safety, Medical Coding, site personnel.
  • Ensure Clinical Data Management staff maintains all relevant documentation associated with each assigned Protocol.
  • Identify and work collaboratively and cross-functionally to implement process improvement measures within data management on both departmental and project level.
  • Coordinate with Clinical Data Management Staff, Client, and Study Team to identify issues/trends for discussion.
  • Lead study/project team meetings as primary facilitator of timelines, providing updates on study status to the cross functional team.
  • Escalate any potential or actual issues in a timely manner and follow issues through to resolution.
  • Contribute to the development and/or revision of Clinical Data Management SOPs and related documentation.
  • Serve as primary point of contact for all project timeline related communication.
  • Monitor and work to maintain/improve stakeholder satisfaction by ensuring high quality service, communication, and management of clinical data.
  • Lead and facilitate all project team meetings.

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsICON, 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, colour, 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 or submit a request here.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.