Senior Clinical Project Manager (all genders)

medac; Wedel; Hybrid; EUR 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Flexible working hours

30 days annual leave

Cafeteria and meals

Zusammenfassung

medac is seeking an experienced leader to guide international Phase I–III clinical studies from planning through delivery in a hybrid setting in Germany. You will oversee CROs and vendors, ensuring quality, timelines and budgets while driving study governance and risk management.

Collaboration with clinical, regulatory, and operational teams is essential. The ideal candidate holds an advanced life sciences degree (PhD preferred) and has a proven track record in global clinical trial design and

Qualifikationen

• Advanced degree in Life Sciences, Pharmacy, Medicine or related field; PhD preferred.
• Proven track record leading international Phase I-III clinical studies.
• Strong knowledge of ICH-GCP and global clinical research regulations.

Aufgaben

• Lead planning, execution and delivery of international Phase I-III studies.
• Oversee CROs and external vendors with accountability for quality, timelines and budgets.
• Establish governance, risk management and performance oversight across the study lifecycle.
• Collaborate with cross-functional teams to align clinical, regulatory and operational priorities.
• Contribute to protocol development, study planning and operational strategies.
• Ensure compliance with ICH-GCP and regulations; maintain inspection readiness.
• Support regulatory interactions, submissions, inspections and audits.
• Promote collaboration and continuous improvement culture.

Kenntnisse

CRO oversight

Vendor management

Study governance

ICH-GCP compliance

Clinical trial design

Cross-functional collaboration

Ausbildung

Advanced degree in Life Sciences/Pharmacy/Medicine

Jobbeschreibung

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