FSP - Regulatory & Start Up Specialist

hace 6 días

Mar del Plata, Buenos Aires, Argentina IQVIA A tiempo completo $30.000 - $60.000 al año

The
R
egulatory and Start-Up Specialist
will 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 Life science or related field
  • Between 1-2 years of relevant experience working in the regulatory department in Argentina:
  • Local and regional committees - Initial submission, Amendments, Response to Pending Issues. You'll be the nexus between the site and the ECs.
  • ANMAT and CCIS - Knowledge of Inclusion of centers (EFCA2) is valuable
  • ICF - Country and Site Specific Customization
  • Essential Documents Collection
  • TMF
  • Update Trackers and Check lists.
  • Advanced level of English
  • Ability to work in a team

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more

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