مساعد تجربة سريرية

Roles and responsibilities

We are seeking a motivated and detail-oriented individual to support Clinical Trial Managers in the coordination and archiving of clinical trials. This role is pivotal in ensuring that all essential documents are managed effectively within our Clinical Trial Management System (CTMS) and electronic Trial Master File (v-TMF). The ideal candidate will play a key role in maintaining compliance with ICH-GCP guidelines and EU directives, thereby contributing to the overall success of our clinical research initiatives.

Key Responsibilities:

As a Clinical Trial Support professional, your primary responsibilities will include:

1. Document Management: Assist in managing essential trial documents, ensuring they are accurately maintained in the CTMS and v-TMF. This includes organizing, filing, and archiving documents to comply with regulatory requirements.

2. Compliance Assurance: Monitor adherence to ICH-GCP standards and EU directives throughout the trial process. Help ensure that all activities are conducted in accordance with regulatory expectations.

3. Onboarding of Clinical Trial Assistants (CTAs): Support the onboarding process for new CTAs by providing training and resources that enable them to understand trial protocols and operational procedures effectively.

4. Meeting Coordination: Organize and coordinate trial-related meetings, including Investigator meetings and safety committee documentation. This involves scheduling, preparing agendas, and ensuring that all relevant materials are distributed in advance.

5. Cross-Functional Support: Collaborate with various teams to ensure effective communication and streamline processes related to clinical trials. Foster a team-oriented environment that encourages collaboration and knowledge sharing.

Desired candidate profile

Qualifications:

To be successful in this role, candidates should meet the following qualifications:

• Experience: A minimum of 3 years of experience in Clinical Operations, with a strong understanding of clinical trial processes and regulatory requirements.

• Regulatory Knowledge: Proficiency in ICH-GCP guidelines and EU Directives is essential. Familiarity with the ethical and regulatory landscape governing clinical research will be advantageous.

• Technical Skills: Experience with electronic Trial Master File (v-TMF) and Clinical Trial Management Systems (CTMS) is required. Proficiency in Microsoft Office Suite (Outlook, Word, Excel, and PowerPoint) is also essential for effective communication and document management.

• Communication and Organizational Skills: Strong organizational abilities are crucial for managing multiple tasks and deadlines. Excellent communication skills are necessary to facilitate collaboration across teams and ensure clarity in all documentation and meetings.