Clinical Affairs Specialist/Manager

New

Adecco is currently hiring a Clinical Affairs Specialist/Manager for our Medical Device Manufacturing client in Ottawa West. This is a permanent opportunity offering full time hours, Monday – Friday. The salary for this position will be determined based on education and experience. The client is also offering bonus and stock options.

Our client is a diversified health care innovator with a legacy of pioneering work in medical diagnostics and devices. They are dedicated to advancing innovative with-patient diagnostic technology to improve patient care and system efficiency by fundamentally changing the way health care professionals process patients through their system.

The ideal candidate will be responsible for management, execution, and implementation for all divisional continuous improvement programs to drive excellence within the Global Clinical Affairs group in concordance with GCP, APOC quality and regulatory compliance. The role will work in close collaboration with the other functions within Clinical group such as Data Management, Statistics, Contracting, Logistics and Writing to deliver improvements from the application of process improvement methodologies and change management.

Clinical Affairs Specialist/Manager Responsibilities:

  • Experienced clinical leader responsible for identifying and leading the implementation of internal process optimization and system/process improvement programs including but not limited to:  Developing tools, systems, and dashboards to monitor effectiveness and enhance quality and efficiency in all areas of the Clinical group
  • Work cross-functionally with the Data Management team, Statistics team, Project Managers and CRAs to evaluate and streamline existing processes
  • Continue to evaluate, develop, and implement best practices across all functional areas of the group
  • Oversee compliance of clinical study sites selection, CRO selections and study monitoring
  • Be proactive to identify risk mitigation strategies.
  • Accountable for delivering results from the application of continuous improvement methodologies and effective change management.
  • Ensure close communication and working relationship with R&D, regulatory, quality, PMO and other functional teams
  • Ensure compliance with GCP, quality and regulatory compliance and other APOC site specific compliances
  • May lead a team of Clinical Affairs professionals
  • Other miscellaneous duties as needed
  • Clinical Affairs Manager/Specialist Requirements:

  • Bachelor’s degree, Engineering, Science or related field, MBA Preferred
  • Minimum 7 years:  Clinical Trials execution experience
  • Minimum 5 years:  Experience across the areas of clinical, regulatory and quality (six-sigma) is a strong asset
  •  IVD Experience preferred
  • Knowledge of Six Sigma tools and process improvement techniques,
  • Certification in process improvement methodologies strongly preferred
  • Well-developed leadership track record in process improvement required
  • Proven leadership and project management capabilities required
  • To be considered for the Clinical Affairs Specialist/Manager opportunity, please Apply!

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    • Apply with Adecco

    Reference number CA_EN_1_021956_1664632

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