Global Start Up Assistant

hace 6 días

Madrid, España Allucent A tiempo completo

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Global Start-Up Assistant to join our A-team

The Global Start-up Assistant (GSUA) provides administrative support to all activities within Allucent’s Study Start-Up & Site Intelligence unit. This may include tasks related to essential document review, regulatory submission preparation, site contracting activities and Start-up management/oversight. The GSUA is a member of the Study Start-Up & Site Intelligence unit.

**In this role your key tasks will include**:

- Pre-populate global templates and forms (incl. study plans)
- Pre-populate study level documents, forms and templates
- Write, control and distribute meeting minutes during GSSU (study) meetings
- Assist study teams in submission preparation
- Assist in set-up of start-up tracking systems in CTMS
- Assist in tracking relevant information and data in CTMS and/or other tracking tools
- Assist in (CTMS) report generation and review
- Check completeness of CTMS for all GSSU areas and follow-up with involved stakeholders where required.
- Initiate and control signature process of study specific GSSU documents
- Assist in document redaction for EU CTR submissions
- Assist other Study Start-Up team members with filing documents in (e)TMF for which they are document owner
- Assist in transferring changes from Study Master site contracts into country
- and/or site specific site contracts
- Assist in arranging translations as applicable

**Requirements**:

- Life science, healthcare, biological science and/or business degree; or equivalent combination of education, training, and experience
- Previous experience in drug development and/or clinical research preferred
- Basic knowledge of GxP, GDPR, and applicable (local) regulatory requirements
- Good written and verbal communication skills including good command of English language
- Representative, outgoing and client focused
- Ability to work in a fast-paced challenging environment of a growing company
- Administrative excellence

**Benefits**
- Employees will receive an internship salary and other benefits through their employment
- Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

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