Assoc Dir, Quality Mgmt / Mgr, Quality Mgmt (Clinical Research Operations) - (R1028315) in United States at IQVIA™

Date Posted: 7/12/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    United States
  • Experience:
    At least 2 year(s)
  • Date Posted:
    7/12/2018
  • Job ID:
    R1028315

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Description

PURPOSE
The job holder is assigned to the US & Canada R&D Solutions Operations team to support Delivery Unit(s), sponsor(s), business line(s) and/or specific tasks as defined by the Line Manager (LM). The purpose of the Job is to work together with global Quality Management, Site Management, QA, regional leadership and other stakeholders in a joint effort to define and elaborate the Regional Quality Plan, carry out and adopt the plan according to the specific needs defined by the scope of assignment, drive quality initiatives in region, to assist clinical staff in improving compliance with relevant ICH-GCP, SOPs, applicable regulatory requirements and guidelines

RESPONSIBILITIES
Be a permanent member in the Quality Management global forum representing the assigned region/Sponsor/assigned business line.
Contribute to the development of the Global Quality Plan, development and improvement of quality management processes, methodology, tools and any preventative action required on the global level.
Participate in global cross-functional working parties focused on quality assessment and improvement as required.
Oversee, adopt and implement the Quality Plan within the region or scope of the assignment, deploy Quality Managers/Specialists across the region/assignment in agreement with Heads of Business lines, oversee the quality management activities in the region including:
Risk identification, assessment and ad hoc management, planning and execution of Quality Management activities within the assigned business line;
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. Contribute to the development/develop a specific Quality Management Plan and Risk Management Program according to the scope of assignment to complement global strategy, monitor the implementation and delivery.
• Provide advice and support to the assigned business line within the scope of the assignment, e.g. Clinical Research Associates (CRA), Line Managers, Delivery Unit Heads, Site Network Managers, CRA Resource Managers and other key stakeholders 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 Heads of assigned business lines 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.
• Prepare periodic reports to Heads of Quality/Operational Management on quality related matters, risk assessments and specific quality improvement initiatives.
• If job holder is delegated as Line Manager:
Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
• Perform any other reasonable tasks as required by the roleAct as the primary contact for Quality Assurance on clinical quality matters– on the level of the assignment.
 

Job Requirements

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 Quintiles corporate standards and SOPs
• Excellent organizational, interpersonal and communication skills
• Excellent judgement and decision-making skills
• Demonstrated leadership and line management skills
• Excellent 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 lead and motivate a clinical team also required
• Ability to travel extensively within the region/country
• Ability to establish and maintain effective working relationships with co-workers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor's degree in life sciences or equivalent nursing qualification with a minimum of 10 years’ experience in Clinical Monitoring including at least 2 years’ experience in a role equivalent to a Clinical Project Manager/Clinical Team Lead preferably within Quintiles; or equivalent combination of education, training and experience.
• Fluent in English.
• 2 years’ experience in Quality Management or Quality Assurance.
PHYSICAL REQUIREMENTS
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• Extensive travel
 
EEO Minorities/Females/Protected Veterans/Disabled

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.


Job ID: R1028315