Clinical Data Specialist: QC, Archiving & Submissions

IQVIA Inc; Bloemfontein; On-site; ZAR 450,000 - 600,000; Full time

Job summary

IQVIA is seeking a Clinical Data Specialist to provide data management expertise to the Clinical Data Management team in support of high-quality data products for customers. The role may include light leadership tasks under the supervision of an SME or Data Team Lead.

Responsibilities include post-lock activities, data review, QA procedures and ensuring timelines set by the PLA Lead are met. Strong communication with the global eArchiving team is essential.

Qualifications

• Bachelor’s degree in clinical, biological or mathematical sciences, or related field.
• Equivalent combination of education, training and experience in lieu of degree.
• Medical terminology exposure.
• Excellent organizational, communication, leadership and computer skills.

Responsibilities

• Provide basic and some comprehensive data management expertise to the CDM team to deliver efficient, quality data management products.
• May undertake team leadership activities under supervision of SME or Data Team Lead or Functional Manager.
• Serve as a Clinical Data Specialist (CDS) with guidance.
• Conduct post lock activities (eArchiving, Hyperlinking).
• Perform comprehensive quality control procedures.
• Comply with timelines set out by PLA Lead.
• May conduct data review.
• Interact with team members to negotiate timelines and responsibilities.
• Develop and maintain communication with global eArchiving team and management.
• File preparation for regulatory submission and site audits.
• May serve as back-up to an SME or PLA Lead.

Skills

Organizational skills

Communication skills

Leadership

Computer skills

Education

Bachelor’s degree in clinical/biological/mathematical sciences or related field

Equivalent combination of education, training and experience

Job description

IQVIA is seeking a Clinical Data Specialist to provide data management expertise to the Clinical Data Management team in support of high-quality data products for customers. The role may include light leadership tasks under the supervision of an SME or Data Team Lead.

Responsibilities include post-lock activities, data review, QA procedures and ensuring timelines set by the PLA Lead are met. Strong communication with the global eArchiving team is essential.