Regulatory and Site Activation Sr Analyst

hace 7 días

Lima, Perú IQVIA A tiempo completo

Job Overview
Under general 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 feasibility or maintenance activities.

Essential Functions

• Under general supervision, 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.

• 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 required documents such as questionaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.

Qualifications

• Bachelor's Degree Life science or related field.

• With 2 years' experience in a healthcare environment working in regulatory activities (contracting, submissions, import, regulatory process, regulatory entity, legislation).


• Good attitude, desire to continue learning, good behavior, good communication.


• English Level: Intermediate - advanced conversational.

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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