Clinical Trial Specialist
vor 12 Stunden
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 systemsAbility 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.
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.
-
Clinical Trial Lead
vor 3 Stunden
Planegg, Bayern, Deutschland Tubulis VollzeitBe part of our team The Clinical Trial Lead (CTL) leads and manages the execution of one or more clinical trials in a fast-paced, dynamic environment. The CTL is responsible for ensuring trials are conducted on time, within budget, and in compliance with regulatory requirements, Good Clinical Practice (GCP), and company Standard Operation Procedures...
-
Clinical Trial Specialist
vor 1 Woche
Planegg, Deutschland Tubulis GmbH Vollzeit**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...
-
(Senior) Clinical Scientist
vor 1 Woche
Planegg, Deutschland Ethris GmbH Vollzeit**Your mission**: We are currently looking for a **(Senior) Clinical Scientist - Drug Development.** Ethris, based in the biotech hub Planegg / Munich, Germany, is a technical innovator in the field of messenger RNA (mRNA) therapeutics, an emerging alternative to gene therapies and protein-based drugs. The company has developed two proprietary technology...
-
Global Head of Pharmacovigilance
Vor 6 Tagen
Planegg, Deutschland Tubulis GmbH Vollzeit**Be part of our team**: The Global Head of Pharmacovigilance in Clinical Development is a strategic leadership role responsible for guiding safety strategy, ensuring compliance, and driving successful trial conduct for Tubulis assets across all stages of development. This leader will direct safety strategy, operations, and regulatory compliance for oncology...
-
Global Program Medical Director
Vor 7 Tagen
Planegg, Deutschland MorphoSys Vollzeit**Global Program Medical Director (gn) - Oncology**: - At MorphoSys, our ambition is to redefine how cancer is treated. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to give more life for people with cancer. - Our success is created by our people and...
-
Manager QA GCP/GLP
vor 11 Stunden
Planegg (Germany), Remote (Germany), Lausanne (Switzerland) Tubulis VollzeitBe part of our team We are a dedicated QA team supporting Tubulis development of antibody-drug conjugates (ADCs) and clinical trials with a strong focus on reliable processes and patient safety. Working closely together, we ensure that quality and compliance are part of every step, from research to clinical application. Our team values open communication,...