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Senior Director Clinical Monitoring/Clinical Quality Assurance

Reference Number: 3051
Location: NJ

Our client is a major global healthcare company.  They have asked us to assist them in their search for a Senior Director Clinical Monitoring/Clinical Quality Assurance.

The Senior Director Clinical Monitoring/CQA is accountable for quality and functional excellence in Oncology Global Monitoring Operations (GMO) through activities covering regional quality management, trial quality management, process improvement, GMO quality compliance and CRA training.  This position establishes and implements global strategies and objectives with the goal to increase and sustain a high quality in GMO.

Major tasks and responsibilities will include:

  • Establishes and implements global strategies and objectives with the goal to increase and sustain a high performance and quality in Global Monitoring Operations, in collaboration with Trial Operations, regions and countries in GMO, with OGD&GMA line functions, and in line with General Medicine International Clinical Research Organization (ICRO) and Clinical Quality Assurance (CQA).
  • Represents GMO in inspections and group audits and coordinates activities for preparation, support during inspections and follow-up actions and commitments.
  • Leads the quality compliance team responsible for the oversight and facilitation of quality and process improvement, and for implementing Oncology and Company quality control within the GMO function through development of Key Quality Indicators and other tools (e.g. Risk Mitigation Action plans), driving self-inspection activities and providing overall support to GMO associates in countries, regions and headquarters.
  • Functional lead of the group of Regional Quality Managers accountable for driving regions, country and site quality through risk management, design of programs to improve quality and monitoring process and developing corrective and/or preventive actions, in collaboration with regional heads of GMO.
  • Functional lead of the group of Trial Monitoring Quality Managers accountable to drive quality for pivotal trials through risk management, identification of key factors critical to the quality of a trial and review of trial and monitoring data to identify trends and addresses signals through interaction.
  • Collaborates with the Head of Oncology QA and other QA associates to address potential quality issues and emerging compliance concerns and recommend solutions.
  • Devises relevant remedial and improvement actions for Corrective Action Plans from Audits and responsible for follow-up on completion and implementation of relevant tasks within GMO and the Development Operation functions.
  • Leads the GMO training team responsible for developing, coordinating, and implementing global Oncology monitoring training strategy for new and experienced monitors and other GMO associates in the CPOs.  Partners with Oncology Global/Country Development and with Global Pharma Development Training to understand and anticipate Oncology specific monitoring training needs and to translate these needs into effective learning and development programs. Accountable for CRA training budget.
  • Leads multi-functional teams within Oncology to implement multi-disciplinary process & quality improvement solutions/initiatives in GMO and/or Development Operations.
  • Ensures compliance with GCP, SOP and Training requirements of the GMO organizations.

We seek candidates with the following qualifications:

  • Bachelor’s degree with significant Life Science experience required.  Advanced degree in Life Sciences preferred.
  • A minimum of 10 years of relevant pharmaceutical experience in development or in the Healthcare industry in a leadership role.
  • Demonstrated leadership in leading initiatives with cross-functional teams and implementation of recommendations.
  • Significant monitoring experience in pharmaceutical and or CRO organization.
  • Extensive knowledge of clinical development process, GCP and clinical project management.
  • Knowledge and experience in international (FDA, EMEA) and local regulations, preferred.
  • Experience and/or knowledge in Quality, preferred.
  • Organizational awareness, including significant experience working cross-functionally and in global teams.
  • Excellent interpersonal, problem-solving, negotiation and conflict resolution skills.
  • Excellent organizational skills, as well as predisposition to process improvement.
  • Excellent communicator and presenter (oral and written), ability to communicate to senior leaders.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3051. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.