مساعد تجربة سريرية

Roles and responsibilities

We are seeking a dedicated Clinical Trial Manager to provide support in the coordination and archiving of clinical trials. The ideal candidate will be responsible for managing essential documents within our Clinical Trial Management System (CTMS) and electronic Trial Master File (v-TMF), ensuring compliance with ICH-GCP guidelines and EU regulations.

In this role, you will assist in the onboarding process for new Clinical Trial Assistants (CTAs) and help organize various trial meetings. Additionally, you will play a vital role in supporting Investigator meetings and the documentation of safety committees.

Key Responsibilities:

• Collaborate closely with Clinical Trial Managers to ensure the efficient coordination of clinical trials.
• Oversee the archiving of trial-related documents, maintaining a well-organized and compliant document repository.
• Manage essential documents in both CTMS and v-TMF to facilitate easy access and retrieval for team members.
• Ensure all activities are conducted in accordance with ICH-GCP and EU directives, maintaining the highest standards of quality and compliance.
• Assist in the onboarding process for new CTAs, providing training and support to ensure they are equipped to contribute effectively.
• Organize and facilitate trial meetings, ensuring that all relevant parties are informed and that agendas are followed.
• Support the documentation process for Investigator meetings and safety committees, ensuring accurate records are kept.

Desired candidate profile

Qualifications:

• A minimum of three years of experience in Clinical Operations, demonstrating a solid understanding of clinical trial processes and regulatory requirements.
• In-depth knowledge of ICH-GCP guidelines and EU directives, ensuring adherence to industry standards throughout trial activities.
• Proven experience with managing (v)TMF and CTMS, demonstrating proficiency in maintaining and organizing trial documents.
• Proficient in Microsoft Outlook, Word, Excel, and PowerPoint, with the ability to create and manage documents and presentations effectively.
• Strong organizational skills, with a keen attention to detail and the ability to prioritize tasks effectively.
• Excellent communication skills, both written and verbal, enabling