Clinical Trials Regulatory Officer – Maintenance Associate at IQVIA

Job Overview:

• As an CTRO-MA, you will be responsible for supporting study delivery during the maintenance phase of the study.
• You will work alongside MLs and CTRMs to complete all necessary maintenance and regulatory activities for selected studies or multi-protocol programs.

Your role will involve understanding the scope of work, budget, and resources to ensure smooth project execution.

• Support, setup, and maintenance of various clinical systems.
• Manage and utilize study dashboards.
• Analyze data and monitor study metrics and compliance.
• Prepare project status reports and presentation materials for internal project team and customer meetings.
• Connect with key internal stakeholders for the project.
• Support resource request processes.
• Assist study teams in maintenance activities.
• Act as a back-up for the Maintenance Lead (ML) when necessary.
• Support EAC management when applicable.
• Escalate quality or compliance issues, delays, and risks to relevant stakeholders.
• Implement solutions for complex process issues.
• Participate in initiatives to support the CTRO-MA community and aid personal development.

Requirements:

• Good knowledge of clinical research domain and applicable regulatory requirements/ guidelines
• Good knowledge of Clinical Systems (CTMS, TMF, Workflows etc)
• Expert with MS Excel and good knowledge of MS Office applications and Spotfire reports
• Strong Analytical skills
• Strong communication and collaboration skills
• Ability to work on multiple projects/tasks balancing competing priorities
• Training and Mentorship: We are committed to your professional growth and will provide you with training and mentorship. Our experienced team members will guide you through the intricacies of the role, ensuring you acquire the knowledge and skills needed to excel. You'll benefit from ongoing support and development opportunities, helping you thrive in your career.
• Career Development: Career development paths that may follow on from this role within the group are for Maintenance Lead roles, CTRM roles, or roles in startup and trial conduct in the wider clinical groups.
• What do we want from you? We will be looking for your engagement, your accountable mindset, drive, enthusiasm, and a determined pursuit of service excellence through regulatory compliance.