Senior Clinical Project Manager (all genders)

medac GmbH; Wedel; Hybrid; EUR 110.000 - 160.000; Vollzeit

Benefits dieser Stelle

Work-life balance

Remote options

30 vacation days

Cafeteria

Pension scheme

Training opportunities

Employee support

Health initiatives

Zusammenfassung

Medac is seeking an experienced leader to drive international Phase I-III clinical studies. You will oversee CROs and vendors, ensuring quality, timelines and budgets while aligning clinical, scientific, regulatory, and operational priorities.

The role requires advanced life sciences education, a PhD preferred, and a strong track record in study governance and risk management. English fluency is essential, with German skills a plus.

Qualifikationen

• Advanced degree in Life Sciences, Pharmacy, Medicine or related field
• PhD preferred
• Proven track record leading international Phase I-III clinical studies
• Strong expertise in CRO and vendor oversight, governance and risk management
• Sound understanding of clinical trial design, protocol development and study execution
• Knowledge of ICH-GCP and global regulations
• Experience with regulatory submissions and health authority interactions is desirable
• Leadership, communication and stakeholder management skills; collaborative mindset
• Fluency in English essential; German skills beneficial

Aufgaben

• Lead planning, execution and delivery of international Phase I-III clinical studies
• Oversee CROs and vendors to ensure quality, timelines and budgets
• Establish and drive study governance and risk management
• Collaborate with cross-functional teams to align priorities
• Contribute to protocol development and operational strategies
• Ensure ICH-GCP compliance and inspection readiness
• Support regulatory interactions, submissions and audits
• Promote collaboration and continuous improvement across teams

Kenntnisse

Study leadership

CRO oversight

Regulatory understanding

Clinical design

Stakeholder mgmt

English fluency

Ausbildung

Advanced life sciences degree

PhD preferred

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
• 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

Our employees are our greatest asset.

And to show our appreciation, we offer attractive benefits:

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

About Medac

We are a strong community: with more than 2,000 employees worldwide, we are committed to improving human health. Our work is more than just a job. With a career at medac, you can make a real difference in the industry. Look into this job opportunity and become part of an exceptional workforce.