Clinical Operations Manager

Actalent; Bayern; Remote; EUR 90,000 - 120,000; Full time

Job summary

Actalent is seeking a Clinical Operations Manager to manage trials from start-up to close-out and ensure high-quality study execution in a regulated environment. This role is 100% remote with a requirement to be located in Germany, offering an immediate start on a contract through February 28, 2027.

The ideal candidate has 5+ years in Clinical Development/Operations, strong ICH-GCP knowledge, and experience working with CROs and cross-functional teams. Fluent English is required.

Qualifications

• Bachelor's degree in Life Sciences, Healthcare, or related field.
• 5+ years of experience in Clinical Development and/or Clinical Operations.
• Strong knowledge of ICH-GCP and international clinical trial regulations.
• Experience working with CROs, vendors, and cross-functional stakeholders.
• Understanding of study oversight, quality management, and regulatory compliance.
• Fluent English (written and spoken).

Responsibilities

• Manage and coordinate operational activities for clinical trials from start-up through close-out
• Collaborate with CROs and external service providers to ensure timely delivery of study milestones
• Support protocol development, informed consent documents, project plans, and safety management plans
• Lead Sponsor Oversight activities and ensure compliance with ICH-GCP and regulatory requirements
• Oversee TMF quality, inspection readiness, risk management, and study quality activities
• Support feasibility assessments, site selection, country allocation, and study budgets
• Coordinate audit and inspection readiness activities
• Drive continuous process improvement initiatives across Clinical Operations

Skills

Clinical Operations

GCP knowledge

Vendor management

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in Life Sciences

Job description

Clinical Operations Manager (100% Remote)

Candidate needs to be located in Germany!

We are currently supporting a leading pharmaceutical company in the search for a Clinical Operations Manager to join their Clinical Operations team on a temporary assignment.

This role is ideal for professionals with strong clinical trial management experience who enjoy working cross-functionally and ensuring high-quality study execution in a regulated environment.

Key Responsibilities

• Manage and coordinate operational activities for clinical trials from start-up through close-out
• Collaborate with CROs and external service providers to ensure timely delivery of study milestones
• Support protocol development, informed consent documents, project plans, and safety management plans
• Lead Sponsor Oversight activities and ensure compliance with ICH-GCP and regulatory requirements
• Oversee TMF quality, inspection readiness, risk management, and study quality activities
• Support feasibility assessments, site selection, country allocation, and study budgets
• Coordinate audit and inspection readiness activities
• Drive continuous process improvement initiatives across Clinical Operations

Requirements

• Bachelor's degree in Life Sciences, Healthcare, or a related field
• 5+ years of experience in Clinical Development and/or Clinical Operations
• Strong knowledge of ICH-GCP and international clinical trial regulations
• Experience working with CROs, vendors, and cross-functional stakeholders
• Understanding of study oversight, quality management, and regulatory compliance
• Fluent English (written and spoken)

What's on Offer?

• Opportunity to contribute to global clinical studies
• Dynamic international environment
• Immediate start preferred
• Contract running until 28 February 2027 (no extension possible)