Regulatory & Start-Up Specialist, Site Start-Up - (1807196) in Seoul, KR at IQVIA™

Date Posted: 4/24/2018

Job Snapshot

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.

Responsibilites

  • Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.

  • • Prepare site regulatory and contractual,reviewing for completeness and accuracy.

  • • Inform team members of completion of regulatory and contractual documents for individual sites.

  • • Review, prepare and negotiate site contracts and budgets with sites as directed

  • • Distribute completed documents to sites and internal project team members.

  • • Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information

  • • Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory ethics, ICF and IP Release documents,by coordinating between RSU Team Lead, Clinical Operations, Feasibility,Site Identification, Project Management and CST

  • • Participate in feasibility and/or site identification activities.



Job Requirements

Required knowledge, skills and abilities:

  • • Understanding of regulated clinical trial environment and knowledge of drug development process

  • • Strong verbal and written communication skills including good command of the English language

  • • Ability to work independently and to effectively prioritize tasks

  • • Good organisational and planning skills

  • • Ability to establish and maintain effective working relationships

  • • Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards

Minimum requirements:

  • • Bachelor’s Degree in life sciences or a related field
  •  CRA/RSU expereince is preferred.
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: 1807196