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
Job Summary
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.
Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
Matching Summary
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.
Skills & Requirements
Must-have
Site Activation activities
Contract negotiations with research sites
GCP/ICH and regulatory guidelines
Quality control of documents
Nice-to-have
Local expertise for timeline planning
Direct contact with sponsors
Excellent organization and prioritization
Excellent communication and interpersonal skills
Key Requirements
+2 years clinical research experience
Health Sciences degree
Advanced command of English language
Experience in regulatory submissions & imports/exports desirable