Regulatory and Start-Up Specialist 1
IQVIA
São Paulo, Brazil
há 3 dias

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and / or international regulations, standard operating procedures (SOPs), project requirements and contractual / budgetary guidelines.

May also include maintenance activities.

Essential Functions

  • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
  • Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.

  • Perform start up and site activation 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.
  • 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, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
  • Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
  • Perform quality control of documents provided by sites.
  • May have direct contact with sponsors on specific initiatives.
  • Qualifications

  • Bachelor's Degree Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience;
  • or equivalent combination of education, training and experience.

  • 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.
  • 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.
  • Ability to work independently and to effectively prioritize tasks.
  • Ability to manage multiple projects.
  • Knowledge and ability to apply GCP / ICH and applicable regulatory guidelines.
  • Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards.
  • Understanding of regulated clinical trial environment and knowledge of drug development process.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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