Clinical Trial Assistant (m/f/d)
If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.
What the job looks like
Each day you'll enjoy a variety of challenges, such as:
- Provide general administrative support to the Clinical Operations Department and assistance to Program Manager(s) and Study Manager(s).
- Coordinate the preparation of study documentation, forms and the development of administrative and filing systems and processes.
- Assist the Clinical Operations teams in completion of all required tasks to meet depart-mental and program goals.
- Being familiar with ICH GCP, appropriate regulations, relevant Grünenthal SOP’s and Grünenthal internal tracking systems.
- Coordinate the on-boarding of new team members.
- Set up, organize and maintain clinical study documentation (e.g. Training Files, Decision Logs, etc.) including preparation for internal/external audits, final reconciliation and archival.
- Coordinate the quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
- Track trial progress within the program teams by reviewing vendor systems
What you’ll bring to the table
To make the most of this role and truly thrive, you should have:
- Bachelor or higher education, preferably in any healthcare or related degree (e.g. Biology, Chemis-try, nursing, etc..). Additional general administration or other title are a plus.Direct experience in protocol authoring or management as a lead author is essential
- Experience in clinical trial administration
- Fluency in ICH-GCP (knowledge in ISO standards is an advantage)
- Fluency in English (verbal and written)
- Excellent knowledge of MS Office and document management systems (e.g. GRACE, eTMF, others)
- Team player with strong interpersonal and communication skills
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