Overview
As Senior Manager, Clinical Operations, you will lead governance and continuous improvement of Clinical Operations processes across regions. You will own SOPs, templates, and process documentation, ensuring compliance and scalable workflows. You will collaborate with QA, Regulatory, and other functions to drive audits, CAPAs, and strategic initiatives. This role combines process expertise with cross‑functional leadership to influence global operations and client-focused delivery. The opportunity centers on shaping efficient, compliant trial processes in precision medicine.
Verantwortungsbereiche
- Own governance and lifecycle management of Clinical Operations processes
- Develop, harmonize, and maintain SOPs, work instructions, tools, and templates
- Identify gaps and simplify processes to reduce complexity and duplication
- Translate regulatory and quality requirements into practical process solutions
- Lead cross-functional governance and decision-making across regions
- Drive process implementation, change management, training, and adoption monitoring
- Support audits, inspections, CAPAs, and strategic improvement initiatives
- Provide Clinical Operations input for proposals, budgets, and client-facing activities
Zentrale Anforderungen
- Bachelor’s degree in life sciences, healthcare, clinical research, business, or related field
- 5+ years of progressive clinical research or operations experience in CRO/pharma/global outsourcing
- Proven experience leading cross-functional/global process improvement initiatives
- Strong knowledge of clinical trial operations, ICH-GCP, regulatory expectations, and inspection readiness
- Ability to influence stakeholders and drive outcomes in a matrix organization
- Influence and stakeholder management
- Facilitation and decision-making
- Change management and communication
- Process mapping and documentation
- SOP development and lifecycle management
- CAPA handling and audit support
