Country Site Activation Specialist

3 days ago

Belgrade City Centralna Srbija, Serbia IQVIA Full time €40,000 - €60,000 per year

Job Overview:
Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level.

Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines. With moderate oversight and supervision, perform tasks at a country/region level associated with site activation 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

  • With moderate oversight and supervision, werve a Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.
  • Prepare site documents, reviewing for completeness and accuracy.
  • Inform team members of completion of regulatory contractual. and other documents for individual sites.
  • Distribute completed documents to sites and internal project team members.
  • Update and maintain 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 required documents such as questionaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.

Qualifications

  • Bachelor's degree in Medicine or Pharmacy (required).
  • Other 1 - 3 years' clinical research or other relevant experience; or equivalent combination of education, training and experience.
  • With 3 years' experience in a healthcare environment or equivalent combination of education, training and experience.
  • Strong written and verbal communication skills, with good command of Serbian and English.
  • Additional languages such as German, French, Italian, or Spanish are highly valued.

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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