Site Start-Up Specialist II - (Europe - Homebased) - Iqvia Biotech

Details:
  • Company: IQVIA
  • Salary:
  • Job Status: Full-Time
  • Location: Stevenage
  • Reference: 46d4175f9ea9833104d582bb7cdb3d957855b1fb
  • Date: 13 hours ago
Description:

Job descriptionIQVIA Biotech is a unique division specialising in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment. The sector we work in is cutting edge with therapies for un-met medical need.IQVIA Biotech Offers Candidates Intensive Onboarding ProgrammesHome-based workingRegular line manager support and oversight ensuring good work/home life balance for proactive career development1000's of online training sessions.Mentorship for all new startersESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:• Performs ad -hoc reviews of investigator study files for expired documents.• Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required and regionally applicable.• Communicates directly with the site, with the Site File Associates/Specialists, or local CRAs in various countries, to obtain corrections to incomplete/incorrect/expired documents. May tracks any action items to CRAs/sites in CTMS.• Oversees the Site File Associate(s) • Reviews eTMF reports on a regular basis to ensure all documents have been filed according to IQVIA Biotech SOPs.• Ensure Periodic Site File Review are completed as per the IQVIA Biotech SOPs.• May review documents received from sites, IRBs/ECs and CRAs to ensure compliance with GCP and IQVIA Biotech's standard operating procedures from maintenance through close-out phase.• In NA, supports the review of site specific ICFs as changes occur during the study. Completes ICF checklists and files IRB approved ICFs throughout the study. Maintains accurate and complete site specific ICF template tracking.• Distributes reportable expedited safety reports and cross reports to sites, as needed, and tracks and files reports in appropriate system(s).• Responsible to send updated documents (e.g. 1572, FDF) to client on a monthly basis as required. • Responsible for review of the ongoing IRB/Ethic Committee (EC) documentation (i.e. IRB continuing review, Amendment approval) and update tracking system as necessary and as applicable to region. • Follows the appropriate IQVIA Biotech and/or sponsor SOPs during conduct of the study.• Ensures all project documentation is appropriately filed per IQVIA Biotech SOPs, or Sponsor SOPs as required. • Supports internal, external and client audits of the Investigator Site Files• Provides updates to manager on a regular basis and communicates any out of scope activities. • Adheres to study timelines, document/escalate study challenges and communicates update to PM/ Manager.• Attends Client meetings as needed & may act as regional lead, as applicable• Supports in creating study specific template documents, per IQVIA Biotech SOP.• For NA only, serves as IQVIA Biotech liaison with Central IRBs and completes IRB submissions.• Participates in financial and/or resource forecasting, as applicable. • Performs other duties as required.#LI-AP22At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at .

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