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Description

Oversees the conduct of Merz sponsored clinical trials to ensure quality and adherence to regulatory requirements.

Essential Duties and Responsibilities

• Clinical Trial Management and Oversight:
  • Manage and oversee local and international clinical trials with investigational medicinal products and medical devices
  • Support detailed planning of new clinical programs and strategies (budget, timelines, operational aspects and feasibility)
• Team Leadership:
  • Represent Clinical Operations as core team member on internal cross-functional Project Teams
  • Lead internal Clinical Sub-teams (e.g. lead meetings, oversee internal deliverables and timelines)
  • Practice professional meeting management
  • Communicate effectively (e.g., perform positive relationship management, stakeholder management, escalation)
• Vendor Qualification and Oversight:
  • Select and assist with qualification of clinical trial vendors
  • Create sponsor and vendor oversight plans
  • Implement oversight plans and measure key performance indicators
  • Oversee vendor proposals, contracts, change orders, invoices, purchase orders
  • Review relevant vendor SOPs and ensure they are fit for purpose
  • Ensure adequate training of vendor personnel including documentation  
• Budget Management:
  • Manage study budgets in according with finance processes (e.g., eBTT, accruals, forecasts)
• Quality Management:
  • Ensure adherence to internal SOPs and relevant regulatory requirements
  • Identify quality risks and implementation of mitigations
  • Provide up-to-date study status reporting on internal information systems and trackers
  • Participate in investigational site visits and/or CRA co-visits
  • Support quality audits and manage CAPAs in collaboration with involved functions
• Document Preparation:
  • Contribute to preparation of key documents (e.g., clinical study protocol, clinical study report, informed consent form)
  • Review study specific plans
• Change Management:
  • Promote effective changes
  • Create an open and trust-building working environment
  • Ensure and support the globalization of the organization
  • Develop and improve internal processes (SOPs, WI, new IT/software initiatives, etc.)
  • Participate in cross functional tasks forces or initiatives as requested

Job Related Qualifications/Skills

Professional Experience

• Required:
  • Comprehensive experiences in different medical indications, different study designs, and different phase of clinical development of medicinal products or medical devices (>5 years)
  • Experiences as a clinical research associate and experiences in other areas in clinical research (>5 years)
  • Significant experiences in the management clinical trials (> 5 years)
  • Significant experiences in clinical study processes
  • Significant experiences in the leadership of interdisciplinary and international teams

Knowledge, Skills and Abilities

• Required:
  • Significant knowledge in clinical research and in the conduct of clinical trials
  • Professional Team Leadership skills
  • Excellent verbal, written communication and presentation skills
  • Knowledge in different medical indications/scientific terminology in different study design
  • Ability to develop tools and processes that increase measure efficiencies of the project

Education

• Required:
  • University degree in life sciences or medical health (Bachelor) or other professional qualifications equivalent to university degree

Behaviours

Motivation

Education

Experience

Licences & certifications