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Quality Monitoring and Compliance

IQVIA

Durham, NC

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JOB DETAILS
SALARY
$86,500–$216,000 Per Year
LOCATION
Durham, NC
POSTED
30+ days ago
Job Overview:

This role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to work together with global or regional Quality Management team(s), functional teams, and other stakeholders in a joint effort to clearly define the global Quality Plan, carry out, and adopt the plan according to the specific needs defined by the scope of assignment, assist staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines.

This role provides advice and supports clinical staff and other relevant key stakeholders with regard to quality control, risk management, and corrective/preventive actions.


Essential Functions:

• Adopt and implement the global Quality Management Plan within the scope of the assignment, this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness.;

• Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.

• Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.

• Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.

• Work in close cooperation with teams to manage non-compliance, quality issues, support in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs.);

Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.;

• Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.

• Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.

• May provide assistance during audits and regulatory inspections to the teams to the extent agreed with the business lines, as required by the applicable SOPs.

• Act as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.

• Prepare periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.

• Upon agreement with the line manager: Perform any other reasonable tasks as required by the role.;


Qualifications:

• Bachelor's Degree Bachelor's Degree or equivalent qualification Req

• Equivalent combination of education, training, and experience.

• Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.

• Knowledge of National and International Regulations and Drug Development processes.

• Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.

• Knowledge of IQVIA corporate standards and SOPs.

• Good organizational, interpersonal and communication skills.

• Good judgement and decision-making skills.

• Strong influencing and negotiation skills.

• Strong computer skills including Microsoft Office applications.

• Excellent problem solving skills.

• Ability to travel within the region/country.

• Ability to lead and motivate a clinical team.

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


IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com


IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe


The potential base pay range for this role, when annualized, is $86,500.00 - $216,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.


IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.


To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.


EEO Minorities/Females/Protected Veterans/Disabled

About the Company

I

IQVIA

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. Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources. We are inspired by the potential and propelled by the possibilities. We share the vision to drive healthcare forward. To see how we can help accelerate progress and achievements. Others are developing these medical breakthroughs. We do our part by using breakthroughs in insights, technology and human intelligence to reimagine and deliver ways to help make them a reality. It’s bigger than better clinical trials. Or advances in technologies and analytics. Or faster insights. It’s about exploring a new path to better health outcomes via Human Data Science. It’s about harnessing the power of the IQVIA CORE™ to channel the insights, commercial and scientific depth, and executional expertise that drive maximum value for our customers. Motivated by the industry we help, we’re committed to providing solutions that enable life sciences companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes forward.
COMPANY SIZE
10,000 employees or more
INDUSTRY
Healthcare Services
FOUNDED
1982
WEBSITE
https://www.iqvia.com/