clinical operations manager

The Clinical Operations Manager (COM) supports the Clinical Development infrastructure and program operations to ensure quality, compliance, and consistency. Oversees operational aspects of all clinical studies worldwide and provides strategic direction for clinical trial operations. Works in tandem with Clinical Research, Biostatistics and Data Management, Regulatory Affairs, Project Management and interacting with other senior level managers across multiple functional areas.

Key responsibilties

• Implementation of clinical development processes and systems, i.e. establish a global set of standards, policies and practices to build a management system to oversee operations worldwide with the objective to continuously improve clinical trial execution.
• Maintenance of critical intra-company and external interfaces and processes in clinical development.
  
  

Main tasks

• Write, maintain and verify compliance to SOPs
• We view study documents, monitoring plans, and vendor contracts/scopes for consistency to ensure that all vendor deliverables are well-defined, guide RFP process.
• Arrange audits
• Organise training
• Documentation/information management (including metrics)
  
  

Requirements

• Thorough knowledge of US and EU clinical trial processes in the pharmaceutical industry
• >5 years experience working in Clinical Research/Operations
• Proactive and the initiative to find creative solutions to problems
• Excellent verbal and written communication skills (English)
• Detail orientated, conscientious and able to prioritise
• Happy to be based in Geneva
  
  

Interested candidates should send their CV, references and a cover letter
by email or regular mail:

Human Resources
Addex Pharma S.A.
12 Chemin des Aulx
1228 Plan-les-Ouates, Geneva
Switzerland

Please quote ref: ClinDev_COM when replying