Key Responsibilities
- Lead the planning, execution, and delivery of international Phase I-III clinical studies
- Ensure successful study conduct through effective oversight of CROs and external vendors, with accountability for quality, timelines, budgets and study objectives
- Establish and drive study governance, including risk management, issue resolution and performance oversight throughout the study lifecycle
- Collaborate closely with cross-functional teams to align clinical, scientific, regulatory and operational priorities
- Contribute to protocol development, study planning and operational strategies to support efficient trial execution
- Ensure compliance with ICH-GCP, applicable regulations and internal standards while maintaining inspection readiness
- Support interactions with health authorities and contribute to regulatory submissions, inspections and audits
- Promote a culture of collaboration, accountability and continuous improvement
Your Profile
- Advanced degree in Life Sciences, Pharmacy, Medicine or a related scientific field; PhD preferred
- Proven track record of successfully leading international Phase I-III clinical studies
- Strong expertise in CRO and vendor oversight, study governance and operational risk management
- Sound understanding of clinical trial design, protocol development and study execution
- In-depth knowledge of ICH-GCP and global clinical research regulations
Our employees are our greatest asset. And to show our appreciation, we offer attractive benefits:
- Your work-life balance is important to us. We offer flexible working hours with the option of working a proportion of those hours remotely, 30 annual vacation days and an excellent cafeteria
- Attractive salaries and success-based bonuses for all medac employees
- Individual training opportunities: Our medac academy offers a wide range of programmes including leadership training, coaching essentials and language classes
- A funded pension scheme and other social benefits
- We care for our employees beyond the workplace and provide advice on caring for elderly relatives as well as offering counselling
- We promote sports and activities to improve our employees’ health
- Experience with regulatory submissions, health authority interactions and inspection readiness activities is highly desirable
- Strong leadership, communication and stakeholder management skills, coupled with a collaborative and results-driven mindset
- Fluency in English is essential; German language skills are beneficial
Senior Clinical Project Manager (all genders) in Wedel Arbeitgeber: Medac Pharma
medac ist ein hervorragender Arbeitgeber, der seinen Mitarbeitenden nicht nur 30 Urlaubstage und eine betriebliche Altersvorsorge bietet, sondern auch individuelle Entwicklungsmöglichkeiten durch die medac Akademie fördert. Mit einer positiven Arbeitskultur, die auf Teamarbeit und Wertschätzung basiert, sowie attraktiven Zusatzleistungen wie Corporate Benefits und einem abwechslungsreichen Angebot in den Betriebsrestaurants, ist medac der ideale Ort für Fachkräfte im Bereich Logistik, die ihre Karriere in einem dynamischen Umfeld vorantreiben möchten.
