Senior Clinical Project Manager (all genders)

HQ medac GmbH; Wedel; Hybrid; EUR 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Flexible working hours

Remote work option

30 vacation days

Excellent cafeteria

Salary and bonuses

Training & academy

Pension scheme

Counselling services

Wellness & sports

Zusammenfassung

HQ medac GmbH in Germany seeks an experienced clinical operations leader to oversee international Phase I–III studies. You will manage CROs and external vendors, ensuring quality, timelines and budgets align with study objectives.

You will drive study governance, risk management and regulatory submissions, working with cross-functional teams to align clinical, regulatory and operational priorities. Fluency in English is essential; German language skills are beneficial.

Qualifikationen

• 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

Aufgaben

• 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

Kenntnisse

Leadership

CRO oversight

Regulatory submissions

ICH-GCP

Stakeholder management

English fluency

German helpful

Ausbildung

Advanced life sciences/pharmacy/medicine 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.