Responsibilities
* develop, implement, and maintain systems to ensure gcp compliance.
* provide gcp support to clinical study teams to reduce compliance risks.
* collaborate with quality assurance, regulatory affairs, and clinical teams to develop gcp-compliant policies and sops.
* support etmf oversight, performing compliance checks and developing risk mitigation strategies.
* support inspection readiness activities and trial-specific training.
* site bimo
* sponsor bimo
* assess and document clinical operations process deviations.
* collaborate with clinical trial teams to identify and improve operational processes.
* interact with clinical development, data management, finance, regulatory, quality assurance, safety & pv, clinical supply, and clinical vendors.
* manage clinical capas and conduct root cause investigations for deviations.
* support compliance assessment, mitigation, and change control processes.
* review essential documents (e.g., clinical protocols, informed consent forms, investigator’s brochures, dsurs, clinical study reports) for gcp adherence.
* perform other duties as assigned.
requirements
* bachelor’s degree in a scientific or related discipline, or 5 years of equivalent experience.
* 3-5 years of etmf experience, including study start-up, maintenance, and quality reviews.
* 3+ years of experience in pharmaceutical industry roles related to clinical trials (e.g., clinical operations, project management).
* experience in quality assurance or quality management activities. Gcp specialist • experience with gcp vendor and site audits preferred.
* ability to manage projects and tasks in a fast-paced environment.
* analytical and critical thinking skills for quality review decision-making.
* knowledge of pharmaceutical industry standards, including ich/gcp guidelines.
* experience with bimo inspections preferred; ema/mhra/pdma experience a plus.
* communication skills, both verbal and written.
* • leadership and problem-solving skills.
* ability to translate strategy into operations and manage multiple priorities.
* ability to work independently with limited supervision.
work environment / physical demands
* primarily office-based with required time in clinical trial settings addressing compliance and documentation.
* requires prolonged periods of computer use for data analysis, documentation, and report generation related to compliance processes.
* may involve lifting office materials up to 20 pounds.
* ability to navigate office and clinical environments for audits and training activities
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