Project Manager Clinical Affairs EU (f/m/d)

ZipRecruiter; Bad Vilbel; Hybrid; EUR 50.000 - 90.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen im Gesundheitswesen sucht einen engagierten Manager für klinische Angelegenheiten. In dieser Schlüsselrolle sind Sie verantwortlich für die Planung und Durchführung von klinischen Studien, insbesondere Bioäquivalenzstudien, und stellen die Einhaltung von GCP-Standards sicher. Sie entwickeln wissenschaftliche Bewertungen und koordinieren Projekte von der Idee bis zur Genehmigung. Mit einem offenen Unternehmensklima und flexiblen Arbeitszeiten bietet diese Position hervorragende Entwicklungsmöglichkeiten. Wenn Sie eine Leidenschaft für klinische Forschung haben und in einem dynamischen Team arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Leistungen

Flexible Arbeitszeiten

Mobiles Arbeiten (bis zu 2 Tage/Woche)

Jobticket für die RMV-Region

Kindergeldzuschuss

Gesundheitsfördernde Angebote

Subventionierte Cafeteria

Gruppenunfallversicherung

Zusätzliche Altersvorsorge

Qualifikationen

• Mindestens 2 Jahre Erfahrung im Projektmanagement klinischer Studien.
• Erfahrung mit Bioäquivalenzstudien und Kenntnisse in Biopharmazie.

Aufgaben

• Planung und Durchführung klinischer Studien gemäß EU/ICH-Recht.
• Koordination klinischer Studien und Überwachung von Auftragsforschungsorganisationen.

Kenntnisse

Projektmanagement klinischer Studien

GCP Kenntnisse

Bioäquivalenzstudien

Biopharmazie

Pharmakokinetik

Fließend in Deutsch und Englisch

Ausbildung

Abschluss in Pharmazie oder Medizin

Jobbeschreibung

Job Description

Caring for People's Health as a Trusted Partner - This mission motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products, and specialty pharmaceuticals, we offer patients, doctors, and pharmacists a wide range of therapeutic options. Around 13,000 employees live our values of Integrity, Entrepreneurship, Agility, and One STADA.

Together we are on an exciting growth journey and want to successfully shape the future of STADA. Do you want to become part of a dynamic, international team and grow with us? Then apply now as: Manager Clinical Affairs (f/m/d) Bad Vilbel Germany (DE) Full-time Permanent Portfolio & Product Development Professionals.

In your role as Manager Clinical Affairs, you will be responsible for the planning, preparation, and project management of clinical studies from phases I to IV, with a focus on bioequivalence studies.

You will oversee the conduct of the clinical studies according to EU/ICH law and ensure compliance with GCP standards. What you can expect: You will develop scientific evaluations and clinical study strategies. As a project manager, you will coordinate clinical studies and supervise contract research organizations and external partners.

A key task of your responsibilities is the review of clinical study documents. As a clinical point of contact, you will accompany development projects from the product idea to dossier approval. You will assess clinical studies within the framework of in-licensing and due diligence projects.

You will prepare scientific opinions and responses to Assessment Reports as part of the approval processes.

Who we are looking for: You have a degree in pharmacy or medicine. You have at least 2 years of professional experience and a proven track record in project management of clinical studies (pharmaceutical industry, contract research organization). You have sound knowledge of GCP. You have proven experience with bioequivalence studies and knowledge in biopharmacy and/or pharmacokinetics. Ideally, you have experience with orphan drug development.

You are fluent in both German and English. You approach your tasks systematically, independently, and responsibly, and are willing to take on cross-functional tasks.

What we offer: An open corporate culture with fast decision-making processes and a lot of potential for your personal development. Individual development and training opportunities. Flexible working hours and mobile working up to 2 days per week (depending on the job profile). Job ticket for the RMV region and Job Bike. Childcare allowance. Health-promoting offers such as or the STADA Gym (free of charge). Numerous additional benefits such as "future payment", group accident insurance, supplementary pension scheme, and chemical industry pension fund. Subsidized cafeteria.

We look forward to receiving your application via our website.

Part-time requests are considered on an individual basis. STADA Group promotes its diverse culture, regardless of gender, age, social or ethnic background, disabilities, sexual orientation, ideology, or religion. We use the strength of this to develop creative ideas, expand our experience, and increase innovative strength.

Our focus is on equal opportunities, respectful cooperation, and the promotion of an inclusive working environment.