Clinical Quality Manager

Reference Number: 895617-W
Type of placement: Permanent, Permanent
Location: Switzerland, North East / Central

Introduction:

Provides strategic and tactical development, implementation, execution and management of the Clinical Operations Clinical Quality Management Program . Oversees ongoing GCP compliance activities by clinical trial management teams and ensures adherence to applicable GCP regulations. Develops, maintains and performs training curricula regarding GCP compliance requirements and methods for Clinical Operations staff, as well as other relevant company functional groups supporting clinical trials.

 

Oversees the development, implementation, maintenance and training associated with Clinical Operations SOPs and other process guidance documents. Oversees the development of clinical trial quality management plans and processes. Provides strategic planning, preparation and support for Regulatory Authority GCP sponsor, clinical site and clinical vendor inspections. Collaborates with and supports Clinical Quality Assurance group as necessary according to Clinical Quality Assurance responsibilities.

Main Responsibilities:

  • Cooperates with Clinical Operations staff and other relevant functional group staff to develop, implement and maintain the Clinical Operations Clinical Quality Management Plan
  • Monitors and identifies Clinical Operations SOP gaps and other work process gaps, and develops strategy for addressing gaps
  • Collaborates with different departments to ensure cross-department SOPs are in accordance with current practices and GCP requirements
  • Leads the development of new Clinical Operations SOPs and Work Process Guidance Documents, as well as maintenance of existing SOPs and Work Process Guidance
  • Supports Clinical Operations staff with interpretation and application of global GCP regulations
  • Provides clinical trial GCP compliance training to Clinical Operations staff as appropriate and necessary
  • Collaborates with Clinical Quality Assurance in the strategic planning, preparation and support of Regulatory Authority GCP inspections, including sponsor, clinical site and clinical vendor inspections
  • Leads development, implementation and maintenance of clinical trial team GCP inspection preparation strategies and associated activities for Clinical Operations staff, as well as other relevant clinical trial functional groups as appointed and required
  • Performs GCP compliance assessments of clinical projects and clinical sites as required and requested
  • Leads the development and maintenance of standard clinical trial Clinical Quality Management assurance documents and plans
  • Develops and implements training material for Clinical Operations staff for job code requirements and career advancement
  • Participates in the development and maintenance of other standard non-quality clinical trial documents to ensure GCP compliance
  • Collaborates with other Clinical Operations infrastructure groups to ensure GCP compliance in activities and responsibilities, incl. Clinical Document Control, and Clinical Information Systems

Qualifications and Experience:

  • BA/ BS degree in a life Science.  Higher degree preferred or equivalent professional experience
  • 5 years Clinical Operations experience, including clinical monitoring and clinical trial management experience
  • Prior GCP compliance and clinical quality management experience would be  preferable
  • Previous experience directly supporting the development of Regulatory Authority GCP inspection support plans and processes would be preferable
  • Previous experience directly supporting a Regulatory Authority GCP sponsor inspection in a key role would be preferable
  • Previous experience directly supporting a Regulatory Authority GCP clinical site inspection would be preferable
  • Previous experience in training would be preferable
  • Good organization and project management skills
  • Good interpersonal and communication skills (both written and oral)
  • Ability to problem solve and delegate appropriate tasks to subordinates
  • Expert knowledge of EU, FDA and other clinical trial regulations, as well as detailed knowledge of ICH and FDA GCP guidelines
  • Strong leadership skills, self-motivated, adaptable to a dynamic environment
  • Able to collaborate effectively with internal project teams and external business partners
  • Proficiency in MS Word, Excel, PowerPoint and SharePoint
  • Ability to creatively solve problems while maintaining operational and regulatory compliance
  • Ability to lead and achieve results through others
  • Strong interpersonal and relationship-building-skills, with the ability to lead process improvement up, down and across of levels of the organization
  • Ability to create, manage and enhance functional relationships among departments
  • Experience with the technical and business issues associated with Clinical Information Systems
  • Ability to collaborate with developers and subject matter experts to establish and determine their technical, functional requirements and performance requirements
  • Ability to maintain knowledge of emerging trends and technologies in IS/IT and Life Sciences
  • Excellent written and verbal communication skills
  • Ability to work in a complex and matrix team environment
  • Possesses innovative and future state thinking
  • Possesses an industry best practices perspective
  • Able and willing to travel up to approximately 25%
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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