Clinical Research Specialist – Clinical Protocol Development

Jobtailor; Guarulhos; Presencial; BRL 120 000 - 160 000; Tempo integral

Resumo da oferta

Jobtailor Brazil is seeking a seasoned Clinical Research professional to lead regulatory and study design activities within our clinical development group. You will prepare clinical reports, modules for marketing authorization dossiers, and scientific posters/articles, representing the department in meetings and with authorities.

The role requires handling highly complex dossiers, performing due diligence on partner studies, and training staff on SOPs and regulatory topics.

Qualificações

• Bachelor’s degree in health-related field is required.
• Postgraduate qualification in Clinical Research or related field.
• Solid experience in Clinical Research.
• Knowledge of clinical study design, regulatory requirements, and ICH-GCP.
• Experience preparing documentation for drug marketing authorization.
• Advanced English proficiency.

Responsabilidades

• Participate in technical meetings, representing the department before company, regulatory agencies, and professional associations.
• Prepare final clinical reports, clinical modules for marketing authorization dossiers, and scientific posters/articles.
• Prepare documents for the drug clinical development dossier and study-specific clinical trial dossiers, including clinical protocols for highly complex projects.
• Evaluate clinical studies conducted by partners through highly complex due diligence projects.
• Critically analyze and review documents prepared by statisticians, such as sample size calculations, statistical analysis plans, and randomization lists.
• Review and develop the department’s standard operating procedures and conduct related training.
• Participate in industry events and conduct internal training on relevant topics.

Conhecimentos

Clinical Protocol Prep

Statistical Analysis Review

Drug MA Documentation

Due Diligence Evaluation

Clinical Report Preparation

Formação académica

Bachelor’s degree in Health-Related Field

Postgraduate Qualification in Clinical Research

Descrição da oferta de emprego

• Participate in technical meetings, representing the department before the company, regulatory agencies, and professional associations
• Prepare final clinical reports, clinical modules for marketing authorization dossiers, and scientific posters/articles
• Prepare documents for the drug clinical development dossier and study-specific clinical trial dossiers, including clinical protocols for highly complex projects
• Evaluate clinical studies conducted by partners through highly complex due diligence projects
• Critically analyze and review documents prepared by statisticians, such as sample size calculations, statistical analysis plans, and randomization lists
• Review and develop the department’s standard operating procedures and conduct related training
• Participate in industry events and conduct internal training on relevant topics

Requirements

• Completed bachelor’s degree in a health-related field
• Specialization or postgraduate qualification in Clinical Research or a related field
• Solid experience in Clinical Research
• Knowledge of clinical study design, regulatory requirements, and Good Clinical Practice (ICH-GCP)
• Experience preparing documentation for drug marketing authorization
• Advanced English proficiency

Core Competencies

Demonstrates expertise in Clinical Research, including clinical study design, regulatory requirements, and Good Clinical Practice (ICH-GCP). Proficient in preparing documentation for drug marketing authorization and conducting training on relevant topics.

Highest-signal resume keywords

ATS Optimization Keywords

Hard Skills

• Clinical Protocol Preparation
• Statistical Analysis Review
• Documentation for Drug Marketing Authorization
• Due Diligence Evaluation
• Clinical Report Preparation

Soft Skills

• Critical Analysis
• Training Development
• Communication Skills

Certifications & Qualifications

• Bachelor's Degree in Health-Related Field
• Postgraduate Qualification in Clinical Research

Industry Keywords

• Clinical Development Dossier
• Standard Operating Procedures
• Scientific Posters
• Clinical Trial Dossiers
• Industry Events Participation