Remote Regulatory & Study Start-Up Analyst I

Intrials Clinical Research; Bogotá; Teletrabalho; COP 101 849 000 - 165 505 000; Tempo integral

Resumo da oferta

Intrials Clinical Research is seeking a Regulatory & Start-up Analyst I to oversee regulatory submissions, start-up tasks, and import/export documentation for trials in Colombia or Argentina with remote work options.

You will collaborate with regulatory bodies, sponsors, and sites to ensure timely approvals, maintain TMF quality, and support study milestones while adhering to ICH-GCP and local regs.

Qualificações

• Bachelor's degree or higher in a health-related field.
• Minimum 2 years in regulatory or related roles in pharma/ CRO.
• Strong knowledge of local clinical trial regulations.
• Solid planning skills for time/scope/quality/budget under supervision.
• Proficient in MS Office and Acrobat.
• Excellent written and spoken English.

Responsabilidades

• Lead regulatory and start-up activities for trials, coordinating with PM, sites and sponsors.
• Prepare and review ethics/regulatory/import/export submissions.
• Track progress and ensure timely approvals and document execution.
• Manage regulatory and logistic deliverables with vendors and teams.
• Provide SOP training and participate in local/international meetings.

Conhecimentos

Regulatory knowledge

Project coordination

English proficiency

Communication skills

Attention to detail

Formação académica

University degree in health-related field

Ferramentas

MS Office

Adobe Acrobat

Descrição da oferta de emprego

Intrials Clinical Research is seeking a Regulatory & Start-up Analyst I to oversee regulatory submissions, start-up tasks, and import/export documentation for trials in Colombia or Argentina with remote work options.

You will collaborate with regulatory bodies, sponsors, and sites to ensure timely approvals, maintain TMF quality, and support study milestones while adhering to ICH-GCP and local regs.