Clinical Trials Regulatory Officer – Maintenance Associate

Описание

Clinical Trials Regulatory Officer – Maintenance Associate

EMEA: Home-Based

Make an impact on patient health!

The Global Site Activation unit within IQVIA has the vision to be the clear market leader in clinical trial site activation driving best in class employee, site and customer experiences, and industry-leading outcomes and we look for passionate people to join our team.

An exciting new opportunity is opening up for you to join the Clinical Trial Regulatory Management (CTRM) and Lifecycle Maintenance Team.

Are you passionate about clinical research and eager to contribute to groundbreaking studies?

As a Clinical trial Regulatory Officer in the maintenance sub-unit, you will play a vital role in managing and delivering maintenance and regulatory activities for selected studies or multi-protocol programs, collaborating closely with the Maintenance Lead (ML).

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.

Join us and be part of a dynamic team dedicated to advancing clinical research and improving patient outcomes. Apply today and contribute to studies that make a difference!

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at