Regulatory Start-up Specialist - languages required

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.
• Review, prepare and negotiate site contracts and budgets with sites, if applicable.
• 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, including contracts, regulatory, ethics, ICF and IP Release documents, in line with project timelines.
• Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.
• May perform Site Selection Visits if a trained monitor.
• May participate in feasibility and/or site identification activities.