Reg & Start Up Spec 2 (R1047293) in St Leonards, Australia at IQVIA™

Date Posted: 11/10/2018

Job Snapshot

  • Employee Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Regulatory and Start Up Specialist (RSUS)

Due to continued growth we are currently seeking Regulatory and Start Up Specialists to join our expanding team. This is an excellent opportunity with ongoing career development opportunities enabling you to define your career pathway within our Global offering. We are seeking a self-starter who can manage challenging timeframes with competing priorities across both Australia and New Zealand. 

Your core responsibilities will include:

  • Perform Study Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
  • Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites in Australia and New Zealand.
  • Prepare / review ethics and regulatory documentation, 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.
  • Ensure all relevant documentation and approvals are in place to authorize Investigational Product release.
  • Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines. Ensure overall project efficiency, quality and adherence to project timelines.

    Skills and Experience required:

  • Bachelor’s Degree in Life Sciences or equivalent work experience
  • 3 years experience Clinical Research or Site Start-Up within a CRO/Pharmaceutical Company, ideally in Australia/New Zealand
  • In-depth knowledge of clinical systems, procedures, and corporate standards.
  • Good negotiating and communication skills with ability to challenge, if applicable.
  • Effective communication, organizational, and interpersonal skills.
  • Knowledge and ability to apply ICH GCP and applicable regulatory guidelines.

Who you are:

  • You are a detailed orientated team player who thrives in a fast pace challenging environment. You will enjoy working on multiple projects with evolving priorities while successfully liaising with both internal and external stakeholders to achieve results.

Job ID: R1047293