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Regulatory and Start-Up Specialist, office-based in Amsterdam (R1055781) in Amsterdam, NL at IQVIA™

Date Posted: 1/10/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Amsterdam, NL
  • Experience:
    Not Specified
  • Date Posted:
    1/10/2019
  • Job ID:
    R1055781

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.

As a Regulatory and Start-Up Specialist, you will have the chance to initiate or develop your career further within clinical research. You are going to be involved in the study startup process of different research projects. You will gain knowledge and skills for working with clinical trials independently in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.

YOUR TYPICAL RESPONSIBILITIES MIGHT INCLUDE:

  • 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
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information
  • 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 ICF and IP Release documents, in line with project timelines
  • Provide local expertise to Regulatory and Start-Up leads and Project team during initial and ongoing project timelines planning

KEY COMPETENCIES FOR THIS ROLE:

  • Excellent time management skills
  • Ability to work close together with team members
  • Attention to detail
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • Good organizational and analytical skills

Are you looking to take the next step and move your career forward? 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.

Connect to great opportunity

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: R1055781