Clinical Data Management Specialist

1 month ago

Swansea, City and County of Swansea, United Kingdom ICON plc Full time

**Job Title:** Clinical Data Management Specialist

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**About ICON plc:**

ICON plc is a world-leading healthcare intelligence and clinical research organization. We advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

We help to accelerate the development of drugs and devices that save lives and improve quality of life.

The Role:

You will be responsible for planning and designing CDMS components directly from interpretation of medium complexity clinical trial protocols. You will act as the primary point of contact during study build for assigned projects for design related questions by the project team.

You will read, ensure understanding and adhere to the study protocol, contract and scope of work for all tasks during set-up, maintenance and close-out of the study.

You will track and keep functional management and those responsible for project management informed of any issues that might affect project target dates, scope or budget and escalate potential problems effectively and in a timely manner.

Responsibilities:

  • Consolidate and complete high-level system requirements documents and manage their review.
  • Develop Custom CRF screens, Edit Check and Dynamic Check specification documents using prototyping methodologies as needed.
  • Perform quality control peer reviews of database related specifications as needed and record comments appropriately.
  • Utilize edit checks from the appropriate library and modify the library edit checks to meet trial specific requirements.
  • Program dynamic checks and discrepancy edit checks to meet trial specific requirements with assistance.
  • Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the CSL.
  • Support the CSL in negotiation of time lines and decision making on the study.
  • Maintain and track meeting minutes, issues and decisions logs, and escalations where appropriate.
  • Take part in study kick off (internal and external) meeting as appropriate.
  • Assess impacts of post-production database related changes and compile change management documentation for review by project team leads.
  • Assess training needs of study team members on an ongoing basis.
  • Provide refresher training to junior CSl level team members as required.
  • Review activity and progress of team members who have been delegated activity.
  • Organize and create training and help oversee and administer training and mentoring for junior levels.
  • Travel approximately 10% domestic and/or international.
  • Typical years of experience 3+.

About the role:

This is a fantastic opportunity to join a leading healthcare intelligence and clinical research organization. As a Clinical Data Management Specialist, you will play a key role in the success of our projects.

You will have the opportunity to work with a talented team of professionals and contribute to the development of innovative solutions.

What we offer:

We offer a competitive salary of $80,000 - $110,000 per annum, depending on experience.

In addition to your salary, you will receive a range of benefits including:

  • Annual leave entitlements.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximize 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.

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