IQVIA Services/Site Activation/Req & Start Up Spec1(R1096501) (R1096501) in Tokyo, JP at IQVIA™

Date Posted: 12/7/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Tokyo, JP
  • Experience:
    Not Specified
  • Date Posted:
    12/7/2019
  • Job ID:
    R1096501

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

PURPOSE
・Under general supervision, perform activities associated with study site initiation process as well as ethics and regulatory
submission process throughout the project lifecycle according regulations, standard operating procedures (SOPs),
project requirements and contractual/budgetary guidelines.
・Conduct the quality control activities by checking the Essential Documents and the Monitoring process to confirm that the
handling/processing of the clinical study related Essential Documents are implemented appropriately throughout the
project lifecycle in accordance with standard operating procedures, good clinical practice, and applicable regulatory
requirements.
RESPONSIBILITIES
・Work with team members in preparation of regulatory submissions per work instructions.
・Work with internal team members or sponsor to secure authorization of regulatory documents.
・Inform team members of completion of regulatory and contractual documents for individual sites.
・Check the Essential Documents within the scope of QC Check using the QC check sheet.
・Review and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording and
budgets.
・Work with legal team members or sponsor to secure authorization of contracts.
Work with Clinical Operations, Project Management and Feasibility on SSU project specific status and
deliverables.
・Resolve site issues and report site status to SSUL.
・Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
・Participate in mentorship and training of less experienced staff.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.



Job ID: R1096501