Quality Specialist - (1625424) in Shanghai, CN at IQVIA™

Date Posted: 9/11/2018

Job Snapshot

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.

JOB PURPOSE:

Support quality control manager to develop local quality control process, implement quality control process and Pre-Approval Inspection (PAI) preparation activities to ensure PAI readinsess in theClinical Study Unit.

ORGANIZATIONAL CONTEXT:

(See Organizational chart attached)

 

SUPERVISED RESOURCES:

KEY ACCOUNTABILITIES:


•         Support Quality Control Manager to develop and implement local quality control process

-          Developing yearly quality control process within CSU 

-          risk identification and assessment through data review and quality control processes (in-house documents review, on-site quality visit)

-          providing support in risk mitigation and planning corrective/preventive actions/guidance for improvement


•         Contribute to the development and implementation of Study Risk Management Plan, monitor the implementation and delivery


•         Work closely with monitoring teams to manage non-compliance and quality issues; assist in planning corrective/preventive actions, as applicable


•         Lead the Pre-approval Inspection activities and act as the main contact person with quality team.

 



Job Requirements

JOB-HOLDER ENTRY REQUIREMENTS:

Education:

Bachelor Degree in Science or equivalent    

 

Experience & knowledge:  

Good knowledge of spoken and written English

Minimum of 4 years of experience in clinical monitoring.

In-depth knowledge of SOPs, CRF, ICH/GCPs.

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Core competencies:

Good organizational, interpersonal and communication skills

Good judgment and decision-making skills

Strong influencing and negotiation skills

Ability to work in matrix teams in an open and professional manner

Strong organizational/prioritization skills for the management of multiple concurrent projects.

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: 1625424