Job Description
4TEEN4 Pharmaceuticals GmbH is developing a novel approach for the diagnosis and treatment of a recently discovered disease mechanism directly linked to acute organ failure, caused by a circulating enzyme in the blood (DPP3). Procizumab is a humanized therapeutic antibody currently in clinical development at 4TEEN4. Additionally, 4TEEN4 is developing diagnostic tests for the detection of severe systemic diseases associated with DPP3.
To strengthen our team, we are looking for a Clinical Trial Assistant (m/f/d) to join us as soon as possible in a permanent full-time position (part-time possible).
- Assists in the coordination and management of clinical trial activities, ensuring adherence to protocols, regulations, and study timelines
- Maintains accurate and up-to-date trial documentation, including trial master files, investigator site files, and essential study documents
- Collects, reviews, and ensures accuracy of clinical trial data, collaborating with internal stakeholders to resolve any discrepancies
- Supports the preparation and submission of regulatory documents and ensure compliance with regulatory requirements
- Coordinates and schedules meetings, prepare meeting agendas, minutes, and presentations, and facilitate communication among study team members and external stakeholders
- Collaborates with cross-functional teams, including Clinical Operations, Data Management, and Pharmacovigilance, to ensure seamless execution of clinical trials
- Bachelor's degree in a life science-related field or equivalent experience as well as Medical Documentation Specialist.
- Prior experience as a Clinical Trial Assistant or similar role in a biotech or pharmaceutical company is preferred
- Basic understanding of Good Clinical Practice (GCP) guidelines and regulatory requirements for clinical research
- Proficiency in Microsoft Office Suite and experience with electronic data capture systems is desirable
- Strong organizational skills with a keen attention to detail
- Excellent written and verbal communication skills
- Ability to manage multiple tasks and prioritize work effectively to meet deadlines
- Proactive and solutions-oriented mindset
- Ability to work independently as well as collaboratively in a team environment.
- Flexibility to adapt to changing priorities in a fast-paced environment
- Prior experience with clinical trial documentation, including informed consent forms, trial master files, and essential study documents
- Proficient German and English language skills, minimum B1 level (Common European Framework of Reference for Languages)
A permanent and exciting position in a company highly motivated to develop a treatment that saves lives.
- The opportunity to fully develop your skills
- Fair and adequate compensation
- Flexible working hours with the possibility of remote work on selected days
- Open and dynamic structures with flat hierarchies and short decision-making processes
- Integration into a welcoming team with a supportive company culture and team events