Clinical Operations Manager

Mantell Associates; Berlin; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A specialist recruitment firm is seeking a dynamic Clinical Operations Manager in Berlin, Germany. This role involves leading the execution of clinical trials, ensuring compliance with regulations, managing site operations, and cross-functional collaboration. The ideal candidate has 4-7 years' experience in clinical operations, is fluent in English and German, and has strong stakeholder management skills.

Qualifikationen

• 4-7 years’ experience in clinical operations roles, ideally in pharmaceutical companies or CROs.
• Strong knowledge of ICH-GCP, local German and EU regulatory requirements.
• Fluent in English and German (verbal and written).

Aufgaben

• Oversee and manage clinical trials (Phase II-III) execution.
• Lead study start-up activities, including site selection and vendor management.
• Monitor trial performance and mitigate risks to deliver on milestones.

Kenntnisse

Clinical trial management

Regulatory compliance

Stakeholder management

Cross-functional collaboration

Process optimization

Jobbeschreibung

Mantell Associates is partnered with a well-established Pharmaceutical company, who is seeking a dynamic and detail-oriented Clinical Operations Manager to join the team in Germany on a contract basis.

In this role you will lead and coordinate execution of clinical trials, ensuring timelines, quality, compliance, and patient safety are maintained across all operational aspects.

Clinical Operations Manager - Responsibilities

• Oversee and manage operational planning, execution, and monitoring of clinical trials (Phase II-III) within Germany and across EU territories
• Lead study start-up activities: site selection, site initiation visits, vendor management, contracts, and ethics / regulatory submissions
• Monitor trial performance: patient recruitment, site activation, data quality, protocol compliance, and timelines; proactively identify and mitigate risks to deliver on agreed milestones
• Collaborate closely with cross-functional functions (Clinical Development, Data Management, Safety, Regulatory, Quality Assurance) to ensure studies are conducted in adherence with ICH-GCP, local regulations, and internal SOPs
• Prepare and present regular operational metrics, status reports, forecasts and escalate issues as necessary to senior leadership
• Support budget tracking, resource allocation, vendor oversight, and ensure operational costs are managed appropriately
• Drive continuous improvement initiatives: process optimization, efficiency improvements, and implementation of best practices in clinical operations workflows

Clinical Operations Manager - Requirements

• 4-7 years’ experience in clinical operations roles, ideally in pharmaceutical companies or CROs, with solid exposure to Phase II / III trials
• Demonstrated experience managing site-based operations, vendor management, regulatory/ethics submissions, and site monitoring oversight
• Strong knowledge of ICH-GCP, local German and EU regulatory requirements, and clinical trial lifecycle
• Excellent communication, leadership and stakeholder management skills; ability to work cross-functionally and manage multiple studies in parallel
• Fluent in English and German (verbal and written) to support documentation, regulatory liaison and site interaction

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at [phone].