Clinical Trial Manager (m|w|d)

Miltenyi Biotec; Deutschland; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading biopharmaceutical company in Germany is seeking a Clinical Trial Manager to oversee clinical trials focused on cell and gene therapies. The ideal candidate will manage trial planning and execution, ensuring compliance with regulations and quality standards. A scientific degree and several years in clinical research are required, along with proficiency in German and English. Join our dynamic team to innovate treatments that tackle serious health challenges.

Leistungen

Flexible working hours

Diversity in the workplace

Personal development opportunities

30 days of vacation

Company pension plan

Qualifikationen

• Several years of experience in clinical research.
• Experience managing international clinical trials according to GCP.
• Strong interest in cell & gene therapies.

Aufgaben

• Plan and manage all aspects of clinical trials.
• Ensure compliance with pharmaceutical regulations and quality standards.
• Develop relationships with internal and external stakeholders.

Kenntnisse

Clinical research management

Stakeholder communication

Project leadership

Knowledge in immunology or oncology

Fluent in German (B2)

Fluent in English (C1)

Ausbildung

Scientific degree in chemistry, biology, pharmacy, or medicine

PhD (advantage)

Jobbeschreibung

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.