Tubulis GmbH
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At Tubulis, we are shaping a new generation of antibody-drug conjugates (ADCs) designed to bring safer, more effective treatments to patients with cancer. By combining proprietary conjugation technologies with deep expertise in biologics, we create targeted therapeutics that unlock the full potential of ADCs.
As our Clinical Trial Specialist (CTS) 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? At Tubulis, curiosity and innovation drive us to transform cancer treatment. We are a fast‑growing biotech where science meets passion—and where you have the chance to grow with us.
Impact that matters : Contribute to breakthrough therapies.
Global mindset : Work in an international, diverse team.
Grow & thrive : Develop your career in a supportive, fast‑moving environment.
Innovation every day : Push boundaries with cutting‑edge science.
At Tubulis, your ideas matter, your growth matters—and together, we make a difference.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Research
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At Tubulis, we are shaping a new generation of antibody-drug conjugates (ADCs) designed to bring safer, more effective treatments to patients with cancer. By combining proprietary conjugation technologies with deep expertise in biologics, we create targeted therapeutics that unlock the full potential of ADCs.
As our Clinical Trial Specialist (CTS) 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? At Tubulis, curiosity and innovation drive us to transform cancer treatment. We are a fast‑growing biotech where science meets passion—and where you have the chance to grow with us.
Impact that matters : Contribute to breakthrough therapies.
Global mindset : Work in an international, diverse team.
Grow & thrive : Develop your career in a supportive, fast‑moving environment.
Innovation every day : Push boundaries with cutting‑edge science.
At Tubulis, your ideas matter, your growth matters—and together, we make a difference.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Research
#J-18808-Ljbffr