Be part of our team

As our Clinical Trial Specialist (CTS) (m/f/d) you support the planning, execution, and close-out of clinical trials in compliance with regulatory requirements, Good Clinical Practice (GCP), and company Standard Operation Procedures (SOPs). This is a critical part of the clinical trial operations team, providing support throughout study start-up, conduct and close-out.  The CTS serves as a central source for internal teams, vendors, and study sites to help ensure smooth and timely clinical trial execution.   

Your mission

• Support clinical study start-up activities, including regulatory submissions, site feasibility, and site initiations.
• Maintain and track essential trial documents (e.g., investigator site files (ISFs), regulatory binders).
• Manage Trial Master File (TMF) and ensure inspection readiness in accordance with ICH-GCP and company SOPs.
• Coordinate daily study operations with CROs, vendors, and investigative sites.
• Assist Clinical Trial Manager (CTM) with oversight of monitoring visit reports, follow-up action items, and site performance metrics.
• Draft and review clinical trial documents, including protocols, informed consent forms (ICFs), case report forms (CRFs), site training materials, and study manuals.
• Organize and participate in study team meetings; take and distribute meeting minutes and follow up on action items.
• Ensure timely and accurate data entry and monitor site and study level metrics (e.g., enrollment, protocol deviations, queries).

Your profile

• Bachelor’s degree in Life Sciences or a related field.  
• 2+ years of experience in clinical research, preferably in biotech, pharmaceutical, or CRO setting.
• Knowledge/ understanding of GCP/ICH guidelines, regulatory requirements, and industry best practices.
• Strong organizational, documentation skills, analytical, and communication skills.
• Excellent verbal and written communication skills.
• Proficient in Microsoft Office, and electronic TMF systems
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Demonstrated ability to work independently and collaboratively in a fast-paced, cross-functional team environment.
• Oncology trial experience is a plus.

Why us?

Flat hierarchies and short decision-making processes; open corporate culture; possibility of mobile working; unlimited contract after probationary period; 30 days' vacation; strong team spirit; personal appreciation of values; multicultural and global team and high level of collegiality; regular team events; mobility allowance; pleasant office atmosphere, modern technology standard.

About us

The development of novel, effective and safe therapies for the treatment of cancer is one of the main challenges for modern medicine. We want to drive this process forward. The main goal of Tubulis is to become a leading company in the field of targeted therapeutics and antibody-drug conjugates (ADCs). With a strong team, our own technologies and innovative therapeutic concepts, we are ushering in a new era in the ongoing fight against cancer and share the vision of helping patients world-wide. Be part of a multidisciplinary and focused team, that works towards getting novel promising ADCs to patients with solid and hematological cancers.