Study Start-up Intern

hace 6 días

Madrid, España Allucent A tiempo completo

These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

The SSU Intern 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 and is a member of the Study Start-Up & Site Intelligence unit.

This position is a full time internship and will be based in our office in Madrid.

**Key Requirements**
- 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 and assist in arranging translations as applicable

**Management,** Learning &** Development **-** Actively support to staff learning & development within the company

**Quality Management **-** Draft and contribute as Subject Matter Expert (SME) in the field of GSSU activities to the evaluation/improvement of processes and procedures within the Quality Management System

**Account Management,** Sales & Acquisition **-** Contribute to good communication and relationships with (future) clients

**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

**Benefits**
- Comprehensive benefits package
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Internal growth opportunities and career progression
- More task variety
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms

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