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Clinical Research Development Analyst
LIBBS FARMACÊUTICA LTDA. Ensure the development of clinical development strategies within established timelines and budgets, assessing efficacy and safety for registration, registration renewal, or clinical data generation .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing clinical development strategies, preparing protocols for clinical studies, and ensuring compliance with regulatory requirements. Proficient in collaborating with stakeholders and preparing clinical registration dossiers to support approval processes.
Highest-signal resume keywords
Clinical Development StrategiesPhase I, II, III, IV Clinical StudiesRegulatory RequirementsClinical Registration DossiersStandard Operating Procedures (SOPs)
ATS Keywords
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Hard Skills
Clinical Study Protocol PreparationClinical Data GenerationEfficacy and Safety AssessmentFinal Clinical Study Report PreparationDue Diligence Processes
Soft Skills
CollaborationCommunication
Certifications & Qualifications
Bachelor’s Degree in Health-Related FieldPostgraduate Degree in Clinical Research
Industry Keywords
Clinical ResearchRegulatory Authority RequestsHealth Authority Approval ProcessesProject PlanningEconomic Feasibility Assessment
About the role
Key responsibilities & impact- Ensure the development of clinical development strategies within established timelines and budgets, assessing efficacy and safety for registration, registration renewal, or clinical data generation
- Assist in preparing protocols for Phase I, II, III, and IV clinical studies
- Execute clinical development activities for protocols, incorporating decision points and criteria in collaboration with the team and management
- Collaborate with internal stakeholders to prepare clinical development plans aligned with regulatory requirements and Marketing and Commercial needs
- Prepare responses to regulatory authority requests related to clinical data
- Assist in preparing the final clinical study report with scientific quality
- Assist in preparing clinical registration dossiers and support regulatory, ethical, and health authority approval processes
- Review package insert text related to Clinical Research data
- Support high-level project planning and prepare Standard Operating Procedures (SOPs)
- Collaborate with the Clinical Research team, internal peers, CROs, research sites, and other partners
- Assist with due diligence processes and the evaluation of potential partners
- Develop clinical development proposals during the conceptual and economic feasibility assessment of projects
Requirements
What you’ll need- Bachelor’s degree in a health-related field
- Advanced English proficiency
- Knowledge of Phase I, II, III, and IV clinical studies
- Postgraduate degree, specialization, and/or master’s degree related to Clinical Research is a plus
- This position is also open to people with disabilities
Benefits
Comp & perks- Meal allowance
- Food allowance
- 100% coverage of Libbs medications
- Vidalink pharmacy benefit
- Profit-Sharing and Results Program (PPR)
- Parking, transportation allowance, or company shuttle
- USE Program: subsidy toward the purchase of equipment used for work, which may also be used for personal purposes
- Flexible benefits (TotalPass, life insurance, private pension plan, medical and dental insurance, and food allowance)
- Remote work
- Flexible working hours (start between 7:00 a.m. and 9:00 a.m.; finish between 4:00 p.m. and 6:00 p.m.)