Regulatory and Start Up Specialist / Senior Site Management Coordinator - office based in Zaventem (R1055583) in Zaventum, Belgium at IQVIA™

Date Posted: 10/7/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    10/7/2019
  • Job ID:
    R1055583

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.

Within this position, you will perform tasks at country level associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. Furthermore, you may participate in feasibility and/or site identification activities.

Your typical responsibilities might include:

  • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Start Up Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.
  • Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Review, prepare and negotiate site contracts and budgets with sites, if applicable.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
  • Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics, Informed Consent Form and Investigation Product Release documents, in line with project timelines.
  • Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
  • Perform quality control of documents provided by sites.
  • May have direct contact with sponsors on specific initiatives.
  • May participate in feasibility and/or site identification activities.

You should have:

  • A Master's or higher level degree, preferred in health care or other scientific discipline; or equivalent combination of education, training and experience
  • General awareness clinical trial environment and drug development process
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
  • Fluent written and verbal communication skills in Dutch and French including good command of English language
  • Good organizational and problem-solving skills and effective time management skills

If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team

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: R1055583