IRT Specialist

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

What you will be doing:

Responsible for providing end-to-end IRT support to clinical project teams including but not limited to gathering study specific IVRS user requirements, creating and enforcing IVRS standards, managing vendor performance, monitoring system change requests, and supporting training & education for stakeholders.

• Execute IRT development process from kickoff to system go live, ongoing system change control, and system closeout.
• Work with the internal stakeholders and IRT vendors to develop study specific IVR requirements, creates and enforces the use of IVRS standards. Responsibilities may include collaboration with vendors and internal stakeholders to define requirements and develop implementation plans. Ensures adherence to IVRS standards, reviews study team business case proposals, and provides final go / no-go decision regarding requests to utilize custom functionality.
• Manage vendor performance and relationship(s) at the study level. Responsibilities may include performing root cause analysis and identifying corrective/preventative actions, and serving as a point of escalation for vendor issues.
• Ensure vendor system development processes align with Merck Quality and System Life Cycle expectations.
• Monitor system change requests. Ensure adherence to IVRS standards, works with the clinical project team to identify system changes and ensure completion of the changes through its life-cycle. Monitors and analyzes system change requests, and identifies corrective actions for utilization of standards.
• May provide support in the following areas:
• data transfer issue resolution between IVRS vendors and shipping depots in support of shipping processes, DOF/ERP specifications, and issue resolution.
• lock & transfer of allocation schedules to IVRS vendors, the requirement document approval process, or the provision of site & Merck user information to IVRS vendors.
• development / maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documents.
• process improvement activities.
• training and education for stakeholders including develop, or assist in development of, reference and/or training material; may provide cross-functional internal and external communication as needed.

You are:

• 2-4 years of experience in clinical supplies, clinical research, or database design & development
• B.A./B.S. in biology, life sciences, computer science, or related field

Knowledge, Skills, and Abilities:

• Demonstrated knowledge of IVRS development processes.
• High level understanding of clinical supply chain within the pharmaceutical industry.
• Knowledge of databases, structure, & corresponding tools used to manage, extract, & report data.
• Working knowledge of clinical development and statistical concepts.
• Effective written and verbal communication skills.
• Ability to organize and manage multiple tasks at one time and meet deadlines in a complex environment working both internal to Merck and external to Merck.
• Average proficiency with Microsoft applications (Word, Excel, PowerPoint, Project).
• Working knowledge of regulatory requirements (e.g., GMP), quality procedures and SOP execution.

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/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.