Quality Specialist at IQVIA

Beijing, Beijing, China

Apply Now

Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

Bachelor's Degree
3 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 IQVIA. Equivalent combination of education, training, and experience
Sound working knowledge of medical terminology, IQVIA 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 Pharmaceutical industry operations
Knowledge of IQVIA corporate standards and SOPs
Good organizational, interpersonal and communication skills
Good judgment and decision-making skills
Good 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
Fluent in English

Responsibilities

Adopt and implement the global Quality Management Plan within the scope of the assignment with the support of a mentoring Quality Manager/Senior Quality Specialist, including: Planning and executing 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, assist in planning corrective/preventive actions, as applicable according to SOPs
Inform 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 operational teams to the extent agreed with Quality Management and as required by the applicable SOPs
Prepare periodic reports to stakeholders 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

Skills

Quality Management

Risk Assessment

GCP Compliance

Corrective Actions

Clinical Monitoring

Clinical Project Management

SOPs

Audits

Regulatory Inspections

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

Land your dream remote job 3x faster with AI

Try Jobo Free