Clinical Trial Associate

vor 2 Wochen

Munich, Deutschland Allucent Vollzeit

**CATO SMS and Pharm-Olam, LLC have merged to form Allucent**

**Allucent **is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. **Allucent **is a non-laboratory environment

**The Clinical Trial Associate (CTA) **acts as the primary administrative support to Allucent clinical study teams, as required by Project Managers and Sponsors, thus ensuring that the clinical trial is conducted in accordance with international regulatory and local regulatory and ethical laws, and guidelines for Good Clinical Practice and Standard Operating Procedures. Assists the study team with the day-to-day conduct of international clinical studies with the guidance of an experienced team member.

**Location: Office-Based - Munich, Germany**

**Languages: English & Germany (required)**

**Responsibilities**
- assists CRAs, Lead CRAs (LCRA), Clinical Team Leaders (CTL) and Project Managers (PM) with the day-to-day administration of clinical studies.
- Tracks critical documents and informs PM / CTL and/or LCRA of outstanding documents.
- Accurately updates and maintains clinical systems within project timelines.
- Prepares, distributes, files, and archives clinical documentation.
- Reviews study files periodically for accuracy and completeness.
- Prepares and distributes clinical trial supplies and maintains tracking information.
- Assists PM / CTL / LCRA / CRAs with collection and filing of critical documents.
- Attends local Investigator and CRA meetings. Records questions and answers, and coordinates with the hotel staff to ensure smooth running of the meeting.
- May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- Performs administrative tasks to support team members with clinical trial execution, as required.
- Prepares Trial Master File according to Allucent SOPs with the guidance of Project Manager and/or experienced CTAs, as required.
- Assists with the preparation of Investigator Site Files, Investigator Manuals and Training Manuals with the guidance of Project Manager, experienced CTAs, as required.
- Assists with returning/archiving study files.
- As needed, communicates with sites regarding trial start-up, conduct, and close-out activities at requested intervals.
- May participate in feasibility and/or site identification activities.
- May attend clinical teleconferences, and prepares and distributes minutes for Sponsor and Project Teams within agreed timelines.

**Requirements**:

- **Fluency in English & German** (spoken and written)
- Customer service orientation
- Strong verbal and written communication skills
- Computer literacy, proficiency in Microsoft Office
- Excellent interpersonal and organizational skills
- Ability to work independently and to effectively prioritize tasks
- Ability to manage multiple projects
- Attention to detail
- Ability to establish and maintain effective working relationships with co-workers and managers.

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