Decentralized Trials Quality Manager

Purpose:

The purpose of the Job is to work together with global Quality Management and other stakeholders in a joint effort to define and execute a Quality Plan for Decentralized Clinical Trials (DCT) to assist staff in improving compliance with relevant ICH-GCP, SOPs, applicable regulatory requirements and guidelines.  The role will provide advice and support to DCT clinical staff and other relevant key stakeholders with regards to quality control, risk management and corrective/preventive actions.

RESPONSIBILITIES:

- Contribute to the development of the Quality Plan and Risk Management Program to ensure the development and improvement of quality management processes, methodology, tools and any preventative action required.

- Participate in global cross-functional working parties focused on quality assessment and improvement as required.

- Oversee, adopt and implement the Quality Plan and oversee the quality management activities in the region including:

• risk identification, assessment and ad hoc management, planning and execution of Quality Management activities within DCT;
• preventative and corrective actions and guidance for improvement.
• monitoring of compliance with the global strategy.
• evaluation of the impact made by the quality management activities.
• measurement of performance.

- Ensure adequate and dedicated communication with Operational Management and Quality Assurance as required.

- Cooperate closely with the relevant stakeholders, support maintaining focus on quality in project delivery.

- Provide advice and support to DCT sites on all aspects of GCP compliance.

- Work in close cooperation with operational teams to manage non-compliance, quality issues; assist in planning corrective/preventive actions, as applicable according to SOPs.

- Inform senior leaders and Quality Assurance of quality issues according to SOPs.

- Work closely with Quality Assurance and clinical staff in case of suspected misconduct as required by the applicable SOPs.

- May provide assistance during audits and regulatory inspections to clinical staff to the extent agreed with the Head of QM and as required by the applicable SOPs.

- Act as the primary contact for Quality Assurance on clinical quality matters for DCT sites.

- Prepare periodic reports to Heads of Quality/Operational Management on quality related matters, risk assessments and specific quality improvement initiatives

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

• Sound working knowledge of medical terminology, clinical monitoring procedures (SOPs), GCP, FDA regulations, quality improvement initiatives and processes

• Knowledge of National and International Regulations and Drug Development process

• Knowledge of CRO or Pharmaceutical industry operations

• Knowledge of corporate standards and SOPs

• Excellent organizational, interpersonal and communication skills

• Excellent judgement and decision-making skills

• Strong influencing and negotiation skills

• Strong computer skills including Microsoft Office and Clinical Management applications

• Excellent problem-solving skills

• Demonstrated ability to work in a matrix environment

• Ability to travel extensively within the region/country

• Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers

MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

• Bachelor's degree in life sciences or equivalent with a minimum of 3-5 years’ prior relevant experience; or equivalent combination of education, training and experience.

• Fluent in English.

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IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.