(Regional) Clinical Study Lead (CSL) (m/f/x)

(Regional) Clinical Study Lead (CSL) (m/f/x)

Permanent employee, Full-time · Gräfelfing

Your mission

Immunic is at the forefront of biotechnological research, dedicated to making a significant impact on global health. We are currently seeking a skilled Clinical Study Lead in our Clinical Development Operations team to oversee and manage the day-to-day operations of our clinical studieson a global level or within the assigned regions or countries. This role is pivotal in ensuring the success and compliance of our clinical studies.

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• Ensure the timely and quality execution of clinical studies according to protocol, GCP guidelines, and regulatory requirements.
• Oversee clinical study feasibility assessments, development, and finalization of key clinical study plans and manuals on a global or regional level.
• Lead cross-functional efforts to define enrollment strategies and plans for the study on a global or regional level.
• Manage and oversee vendor relationships, ensuring compliance and efficiency in contracted activities on a global or regional level.
• Represent Clinical Development Operations on Clinical Study Teams, ensuring cross-functional deliverables are met throughout the study on a global or regional level.
• Train and mentor junior clinical team members, ensuring adherence to quality, timelines, and budget.

Your profile

• A BA/BS or higher in nursing, life, or health sciences is preferred. Relevant industry experience may be considered in lieu of education.
• Proven experience in executing a broad range of clinical study activities from initiation to clinical study report.
• Expertise in selecting and managing external service providers, and managing clinical studies in a fully outsourced model.
• Exceptional attention to detail, organizational skills, and a professional demeanor focused on compliance and responsibilities.
• Strong ability to work effectively and independently in an innovative and flexible environment.
• Excellent interpersonal skills with the ability to work as an effective team member and with cross-functional groups.
• Capable of handling multiple responsibilities and working well under pressure.
• Excellent verbal and written communication skills in English with german as a pre.
• Extensive experience in the pharmaceutical industry and clinical research.

Why us?

• A pivotal role in a globally operating, dynamic team.
• The opportunity to contribute to innovative clinical programs that make a real difference.
• A dynamic working environment with opportunities for personal and professional growth.
• A dedicated and supportive team.
• The chance to work on exciting and challenging projects.

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About us

Immunic Therapeutics is a dynamic biotechnology company with a pipeline of selective, orally available immunology therapies for the treatment of chronic inflammatory and autoimmune diseases. Currently, three small molecule product candidates are in various stages of clinical development. For more information, please visit:Â www.imux.com.

We are looking forward to hearing from you!

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