IRT Systems Project Manager

Description

The team designs and runs Interactive Response Technology (IRT) systems for global clinical trials, and this role leads that work from design through go-live.

You will advise pharma and biotech clients on how to turn complex trial protocols into IRT designs that make sure each patient gets the right treatment for the whole study. You will guide them on system strategy, study setup and good practice, and you will manage each project from start to finish.

The role mixes hands-on IRT knowledge, client consulting and project leadership across a varied set of clinical studies.

Responsibilities

• Read clinical protocols to grasp study goals and what the system must do.
• Work with clients to build IRT designs that match protocol rules and operational aims.
• Recommend system design and study setup choices to clients.
• Write and maintain detailed user requirements and design documents.
• Review, refine and sign off requirements with clients and internal colleagues.
• Lead delivery of assigned IRT studies so milestones and deadlines are met.
• Prepare studies for launch before First Patient In (FPI).
• Track scope, spot risks, and handle change requests and their budget effects.
• Organise cross-functional teams to deliver project outputs.
• Run system quality reviews and support client demos throughout each project.
• Coordinate internal and client User Acceptance Testing (UAT), and work with technical and validation teams so systems meet study needs.
• Guide clients through UAT and resolve their questions and issues.
• Make sure test results are recorded accurately and fixes are in place before production release.
• Act as the subject matter expert (SME) for IRT design and implementation.
• Help with process improvement, standards work and lessons learned.
• Support protocol amendments and system changes across the study lifecycle.
• Hand over studies and train operational teams.
• Mentor junior staff and contribute to technical training.
• Support client meetings, bid defence presentations, quarterly business reviews and audits as needed.

Requirements

• Bachelor's degree or an equivalent mix of education, training and experience.
• Several years in clinical research, clinical technology, project management or a related field.
• Hands-on experience delivering and managing IRT solutions.
• Solid grasp of clinical trial operations, patient randomisation and clinical supply management.
• Experience working directly with sponsors, CROs or other external partners.
• Proven skill at reading clinical protocols and turning them into system solutions.
• Strong client-facing consulting and relationship management skills.
• Excellent planning, organisation and prioritisation skills.
• Exceptional written and verbal communication.
• Strong analytical and problem-solving ability.
• Ability to juggle several projects and deadlines at once in a busy environment.
• High attention to detail and a commitment to quality.
• Works well in a team and can work independently.
• Proficient with Microsoft Office and other business applications.

Conditions

Applications must be truthful and complete, as false statements or omissions can lead to disqualification or later termination under applicable law.