Clinical Trial Manager (m|w|d) at Miltenyi Biotec

Bergisch Gladbach, North Rhine-Westphalia, Germany -

Full Time

Start Date

Immediate

Expiry Date

03 Feb, 26

Salary

0.0

Posted On

05 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trials, Project Management, GCP, Immunology, Hematology, Oncology, Autoimmune Diseases, Cell Therapies, Gene Therapies, Communication, Stakeholder Management, Quality Assurance, Regulatory Affairs, Clinical Research, Team Leadership, Proactive

Industry

Biotechnology Research

Description

Company Description Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. Join our highly professional team in bringing new medicines to market and ensuring the safety of our pharmacological developments at all stages. Job Description You are working in the “Clinical Research & Development” department which conducts first-in-man clinical trials and Phase I-II proof-of-concept studies for our new assets worldwide. As Clinical Trial Manager you are responsible for the planning, execution and management of all aspects of clinical trials, primarily in the field of cell and gene therapies. You ensure that all trials are conducted out in accordance with all relevant pharmaceutical regulations (e.g. GCP and applicable SOPs), quality, budget and timelines. You develop effective relationships with internal and external stakeholders and work in regular and very close contact with colleagues from Quality Assurance, Regulatory Affairs, R&D, Manufacturing, Clinical Supply Chain Management, study sites, relevant third parties such as CRO’s, laboratories and auditors, as well as with regulatory authorities and ethic committees. Within the Clinical Clinical research team, you work to continuously improve the required SOPs. Qualifications You have successfully completed your scientific degree (for example in chemistry, biology, pharmacy or medicine or similar); a PhD would be an advantage. You already have several years of professional experience in clinical research and in the management of (international) clinical trials according to GCP. Experience in clinical monitoring is an advantage. Ideally, you have a solid background in immunology, hematology, oncology or autoimmune diseases and are strong interest in cell & gene therapies. You are a self-starter, proactive, goal-oriented and are an experienced project team leader. You are naturally communicative and you communicate confidently and appropriately in both German (B2) and English (C1). You are willing to undertake international travel (approx. 10-20% of your time). Additional Information What we offer Working with free and self-determined time management, also mobile working An intercultural environment characterized by diversity and flat hierarchies Freedom to contribute creatively and play an active role in shaping the company Individual further training in our Miltenyi University as the core of the Miltenyi DNA 30 days of vacation, discounted ticket to Germany, (e)-bike leasing, capital-forming benefits, company pension plan, disability insurance, canteen, and much more. Diversity is the bedrock of our creativity Our mission: To innovate treatments and technologies and tackle the world’s most serious health challenges. And that’s why we connect the dots – across various disciplines, linking different perspectives, skills, and abilities. You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender, sexual identity, age, ethnicity, religion or disability. Become part of our team and focus on pushing the borders of medicine. We look forward to your application If you would like to work in an open, creative and helpful team, we offer you the right environment here. We look forward to receiving your application - with your salary expectations and availability. Internal application deadline: 13.08.2025 Internal contact details: Abidé Papaki-Gbadoe (HR) 0162 2345951 Sanjaykumar Madhukar Patil (line manager; Clinical Data Management) +49 160 98970150 HRC0023351 Internal job title: Clinical Trial Manager

Responsibilities

As a Clinical Trial Manager, you will be responsible for the planning, execution, and management of all aspects of clinical trials in the field of cell and gene therapies. You will ensure compliance with pharmaceutical regulations and develop relationships with various stakeholders.