Clinical Systems Specialist

Overview

As a CTMS Business Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

The Systems Analyst is responsible for supporting systems / processes for any system supported by Clinical Trials Management Solutions team and mainly includes study build activities in Clinical Trial Management System (CTMS), troubleshoot issues, ensure high quality data and smooth integration between CTMS and other systems.

In addition, it includes participation in / lead operational strategy projects related to CTMS.

The services require to work closely with other team members to ensure system impact is assessed and mitigation strategies are in place where applicable.

A clear understanding on the needs of clinical trials / programs and internal or external stakeholders.

Deliverables :

• Services rendered will adhere to applicable sponsor SOPs, WIs, policies, local regulatory requirements, etc.
• Work with Study Teams and partners during study build process to create / maintain the following in CTMS System Support :
• Study, Country, Site, Contacts, and Institution records.
• Create and set up templates such as Health Authority, IRB / IEC, Financial Disclosure, Subject Visit, Visit / Trip Report, etc.
• Update system dropdown values.
• Create / Update assignments, configurations, properties, attributes, triggers, and parameters in the system.
• User administration.
• Import / Export templates.
• Add Payees and study triggers.
• Visit Schedules.
• Subject deviations / central findings.
• Any other general study build activities.
• Troubleshoot integration errors between CTMS and other applications.
• Lead in analysing large data sets
• Lead with User Acceptance Testing (UAT) activities.
• Provide general business support for CTMS, and other applications supported by the Clinical Trial Management Solutions team.
• Create / Generate reports.
• Create and run SQL queries.
• Support Ticket generation / creation and maintenance (tracking of issues / requests).
• Create / Update reference and training materials / documentation.

Qualifications

Education and Experience Guidelines :

• Bachelor’s degree (University degree) or equivalent education required, advanced degree preferred.
• 3-5 years of professional experience
• Demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning is required
• Prior experience with Medidata CTMS and / or Siebel CTMS or other Clinical Trial Management systems preferred.
• Knowledge of the Clinical Trial Management process
• Proficient in using MS Office Suite of applications including Visio and advanced Excel skills
• Should have Problem Solving skills and good communication skills
• Oracle SQL experience.
Must Haves :
• Oracle
• Oracle
• Running Queries
• Writing Scripts
• Process Documents, analytical support
• Understanding Trends, efficiencies, problems

Why 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.

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.

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, 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.

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.

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