(Senior) Clinical Trial Manager (m/f/d)

At HELM Pharmaceuticals, based in the Headquarter in Hamburg, we develop generic pharmaceuticals.

To strengthen our team in the Finished Dosage Form Programs we are looking for a Manager Clinical Development (m/f/d) with a clinical life science background.

In this position, you combine scientific expertise with strategic thinking, you help shape a high‑quality development pipeline and contribute to strong regulatory outcomes. You will work closely with interdisciplinary teams and external partners to drive projects forward efficiently. This role offers you the opportunity to actively influence clinical development decisions and create real value for customers. Become part of a dynamic environment where your work has a real impact!

Your tasks:

• You ensure the continuous proof of efficacy and safety for our developed products across all life‑cycle stages.
• Furthermore, you also provide qualified responses to scientific and regulatory questions related to trial design, evidence requirements, and portfolio selection
• In addition, you will represent our clinical development in interdisciplinary generic development teams with emphasis on clinical trials of medicinal products.
• As Trial Manager, you plan, coordinate, and supervise clinical and/or pre‑clinical studies in line with regulatory guidelines and maintain quality management of the entire trial program. This also includes consultation and design of trial concepts with competent authorities and the preparation of scientific advice packages.
• Part of your role will also include tasks as a Medical Writer, where you prepare and review scientific documentation on the efficacy and safety of our products. Here, you ensure the timely preparation of non‑clinical and clinical documentation for regulatory submissions, including the commissioning and review of modules 2.4 and 2.5.
• In doing so, you respond to deficiency letters during registration procedures and manage corresponding customer inquiries.
• Moreover, you identify, select, commission and collaborate with national and international service providers (CROs, monitors, consultants), including auditing and ensuring proper investigational medicinal product handling in line with GCP and GMP requirements.
• Lastly, you collaborate with the project teams in due-diligence processes and evaluate dossiers as part of in‑licensing activities.

Your profile:

• You hold a university degree in a life‑science discipline.
• Moreover, you have a solid understanding of clinical research with more than 3 years of experience.
• You combine scientific rigor with a hands‑on mentality and a structured, solution‑oriented way of working.
• You communicate effectively with interdisciplinary teams and external partners and feel comfortable managing several projects simultaneously.
• You are familiar with common IT applications within the framework of project management (MS Office). In top of that, you already gained experience in working with SAP or another ERP system.
• Fluent spoken and written English skills complete your profile.