Clinical Research Analyst
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Job Description
Clinical Research Analyst managing clinical protocols and submissions for regulatory approval in a dynamic environment. Working remotely with Synvia to enhance lives by supporting pharmaceutical innovations.
Responsibilities:
- Handle sponsor requests with the required level of detail and grounded in current legislation;
- Participate in discussions to define the best strategy for different projects;
- Assist in project feasibility assessments;
- Assist in identifying potential risks and opportunities for projects resulting from changes in legislation and/or applicable requirements;
- Conduct literature reviews for the preparation of clinical study documents, regulatory-scientific opinions, and Investigator's Brochures;
- Draft clinical study protocols and related documents;
- Prepare Investigator's Brochures;
- Adapt prepared documents, when necessary, following review by project stakeholders;
- Prepare the complete project dossier for submission to the CEP/CONEP system via Plataforma Brasil;
- Prepare and submit amendments, notifications, interim reports, protocol deviations, or responses to outstanding queries to the CEP/CONEP system;
- Respond to internal monitoring/audits conducted by the Quality Assurance department;
- Contribute technical responses to requests issued by competent authorities;
- Archive research project documents in accordance with internal procedures;
- Keep the project database updated according to internal procedures;
- Review Standard Operating Procedures (SOPs) relevant to the department and, if necessary, assist in managing the area's training matrix;
- Participate in Regulatory and Scientific Affairs meetings and as requested;
- Participate in technical meetings with sponsors alongside the Regulatory Affairs and Start-Up Management team, when necessary;
- Stay up to date with regulations and technical requirements applicable to the Brazilian regulatory agency and international guidelines for planning, conducting, and submitting projects.
Requirements:
- Bachelor's degree in Pharmacy-Biochemistry, Biomedicine, Biology, Biotechnology, or related fields.
- Experience writing clinical protocols for ANVISA submission, including systematic literature reviews for the preparation of clinical and non-clinical modules composing a drug registration dossier;
- Knowledge of CTD (Common Technical Document);
- Strong writing skills;
- Advanced English;
- Basic Spanish;
- Advanced MS Office skills;
- Training in Good Clinical Practice (GCP).
Benefits:
- Transportation allowance;
- Parking (subject to availability);
- Health insurance with no monthly premium for the employee, with co-pay for tests and consultations;
- Dental plan with employee co-payment;
- Life insurance at no cost to the employee;
- Flexible meal/food allowance;
- Pharmacy discount program;
- Synvia Partnership Club (educational institutions, language schools, leisure and cultural partners);
- Partnership with SESC;
- Physical wellness program - TotalPass;
- Day off for health professionals;
- Childcare assistance (per internal policy).
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