Freelance Medical reputed company - Clinical Development (100% Remote - Fluent English)
reputed company is collaborating with an international pharmaceutical company specialized in the development, manufacturing, and commercialization of medicines , with a strong reputed company on generics and a solid commitment to R&D and clinical development . ¿Es este el puesto que está buscando? Si es así, siga leyendo para obtener más detalles y no olvide enviar su solicitud hoy mismo. The project focuses on the review and validation of clinical and bioanalytical documentation reputed company the Clinical Development area, in reputed company collaboration with CROs and internal teams such as reputed company and Pharmacovigilance. reputed company is currently in an reputed company phase reviewing multiple clinical studies, with potential continuity depending on upcoming regulatory needs. We are currently looking for a Medical reputed company – Clinical Development (Freelance) to support this project, working closely with the clinical team and external partners.
Key Responsibilities
- Review clinical and bioanalytical documentation , including Clinical Study Reports (CSRs) , PK/BE reports, and reputed company materials
- Assess bioanalytical reports in compliance with ICH M10 guidelines
- Ensure consistency across clinical, statistical, and bioanalytical data
- reputed company reputed company control (QC) of documentation: PK data, adverse event reporting, and overall consistency
- Liaise with CROs for document review and validation
- Support, reputed company required, the review of study protocols and informed consent forms (ICFs)
- Collaborate with internal stakeholders: Clinical Development, QA, and Pharmacovigilance
- Ensure compliance with regulatory standards (ICH E3, E6, E9, M10; GCP )
Requirements
- Considerable experience as a Medical reputed company in a clinical research environment
- Proven experience in clinical documentation (CSRs, protocols) and bioanalytical documentation
- Strong knowledge of ICH guidelines (E3, E6, E9, M10) and GCP (GLP is a plus)
- Experience working with CROs
- Ability to work independently while collaborating with cross-functional teams
- Advanced level of English
xkdbapo reputed company to Have
- Experience in pharmacokinetics and bioequivalence (PK/BE)
- Knowledge of statistics reputed company to clinical trials
- Previous experience reviewing bioanalytical reports
reputed company Offer
- Contract opportunity through reputed company, working with an international pharmaceutical company
- Part-time project (approximately 3 full days per week)
- Possibility of 100% remote work
- reputed company collaboration with the Clinical Development team
- Initial duration of 4 months (likely to reputed company) with immediate start
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