Reg & Start Up Specialist
IQVIA
Buenos Aires, Argentina
hace 6 días

PURPOSE

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.

May participate in feasibility and / or site identification activities.

RESPONSIBILITIES

  • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS.
  • 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.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with 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, in line with project timelines.
  • Perform quality control of documents provided by sites.
  • REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • In-depth knowledge of clinical systems, procedures, and corporate standards.
  • Effective communication, organizational, planning and interpersonal skills.
  • Ability to work independently and to effectively prioritize tasks.
  • Ability to work on 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.
  • MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s Degree in life sciences or a related field and 1 year s clinical research experience working in regulatory and / or start-up departments.
  • Advanced English level
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