مساعد تجربة سريرية

Roles and responsibilities

We are seeking a dedicated and detail-oriented professional to support our Clinical Trial Managers in the coordination and archiving of clinical trials. This position plays a crucial role in managing essential documents within our Clinical Trial Management System (CTMS) and electronic Trial Master File (v-TMF). The ideal candidate will ensure compliance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and European Union directives, which are essential for the successful conduct of clinical trials.

In this role, you will assist with onboarding new Clinical Trial Associates (CTAs) and help organize and coordinate trial meetings, ensuring all stakeholders are aligned and informed. You will also provide support for Investigator meetings and manage documentation for safety committees, ensuring all records are accurate and accessible. Your contributions will be vital in facilitating smooth operations within our clinical trial processes, ultimately supporting the advancement of innovative therapies and improving patient outcomes.

If you are excited about the opportunity to support clinical research and play a key role in the advancement of new therapies, we would love to hear from you! Please submit your CV through LinkedIn. Join us in our mission to improve patient health outcomes and be part of a team that values innovation, collaboration, and dedication. Your expertise could make a significant impact on our clinical trial efforts, helping to bring life-changing treatments to patients in need. We look forward to reviewing your application and exploring how you can contribute to our important work in clinical research.

Desired candidate profile

Qualifications

To be successful in this role, candidates should possess a minimum of three years of experience in Clinical Operations. A solid understanding of ICH-GCP and EU directives is essential, as these regulations guide the ethical and scientific quality of clinical trials. Familiarity with (v)TMF and CTMS is also required, as you will be managing and archiving critical trial documents that ensure compliance and integrity throughout the trial lifecycle.

Proficiency in Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint, is necessary to perform daily tasks efficiently. Strong organizational skills will enable you to manage multiple priorities and deadlines effectively, while excellent communication skills will be crucial for interacting with team members, stakeholders, and external partners.

We value individuals who are passionate about clinical research and are committed to making a difference in the field. If you thrive in a fast-paced environment and are eager to contribute to the success of clinical trials, we encourage you to apply.