Clinical Research Development Analyst

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Oversee the formulation of clinical development strategies within defined timelines and budget constraints, evaluating efficacy and safety for registration, renewal of registration, or generation of clinical data.

• Aid in the preparation of protocols for Phase I, II, III, and IV clinical trials.

• Implement clinical development activities for protocols, integrating decision points and criteria in conjunction with the team and management.

• Work alongside internal stakeholders to develop clinical development plans that comply with regulatory requirements and align with Marketing and Commercial objectives.

• Craft responses to inquiries from regulatory authorities concerning clinical data.

• Assist in the creation of the final clinical study report, ensuring scientific rigor.

• Help prepare clinical registration dossiers and facilitate regulatory, ethical, and health authority approval processes.

• Review text for package inserts related to Clinical Research data.

• Support high-level project planning initiatives and develop Standard Operating Procedures (SOPs).

• Collaborate with the Clinical Research team, internal colleagues, CROs, research sites, and other partners.

• Contribute to due diligence processes and assess potential partners.

• Formulate clinical development proposals during the conceptual and economic feasibility evaluations of projects.

⛳️ Requirements

• Bachelor’s degree in a health-related discipline.

• Proficient in advanced English.

• Familiarity with Phase I, II, III, and IV clinical trials.

• A postgraduate degree, specialization, and/or master's degree in Clinical Research is an advantage.

• This position welcomes applications from individuals with disabilities.

🏝️ Benefits

• Meal allowance.

• Food allowance.

• Full coverage of Libbs medications.

• Vidalink pharmacy benefit.

• Profit-Sharing and Results Program (PPR).

• Parking, transportation allowance, or company shuttle.

• USE Program: subsidy for purchasing work-related equipment, which can also be utilized for personal use.

• Flexible benefits (including TotalPass, life insurance, private pension plan, medical and dental insurance, and food allowance).

• Remote work options.

• 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.).