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).
Clinical Trial Assistant (m/f/d)
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