Central Monitor II

🕒 Junho 11

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Syneos Health

SiteLinkedInTodas as Vagas

10.000+ funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

Syneos Health é uma organização líder, totalmente integrada, de soluções biofarmacêuticas, criada para acelerar o sucesso dos clientes. A empresa transforma insights exclusivos clínicos, de Assuntos Médicos (Medical Affairs) e comerciais em resultados para responder às realidades modernas do mercado. Ao utilizar tecnologias avançadas e insights, a Syneos Health colabora com os clientes para acelerar a entrega de terapias importantes a pacientes no mundo todo, oferecendo serviços que abrangem todo o espectro do clínico ao comercial.

Descrição

• Performs remote patient data review activities for Phase I-IV clinical research and/or non-interventional studies (NIS) to assess compliance with the protocol, ICH-GCP, and/or all applicable local and federal regulatory requirements. • Ensures patient safety and data integrity using a variety of technologies. • Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution. • Reviews patient data listings and visualizations via analytical dashboards and/or reports to confirm eligibility, identify protocol deviations, patient safety concerns, data integrity issues and illogical/inaccurate/missing data. • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. • Immediately communicates/escalates serious issues to the project team and with guidance develops action plans. • Documents observations noted during reviews and writes queries, protocol deviations or action items as necessary in appropriate systems for action by sites, CRAs or other functional team members. • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. • Accesses vendor systems or reports to verify the IP has been dispensed and administered to subjects/patients according to the protocol, that laboratory and other procedures have been performed, that eTMF data is current and complete. • Documents completion of activities via tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan. • For assigned activities, understands project scope, budgets, and timelines; manages patient- and site-level activities to ensure project objectives, deliverables and timelines are met. • Prepares for and attends Investigator Meetings and/or sponsor meetings.

🎯 Requisitos

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience. • Knowledge of Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements. • Must demonstrate good computer skills and be able to embrace new technologies. • Mastery of MS Excel (sorting, filtering, calculating, pivoting). • Proficient with Analytical Data Visualization Tools (adjusting visualizations, selecting subsets of data to analyze). • Excellent verbal and written communication skills to relate to internal stakeholders. • Strong analytical skills. • Developing therapeutic expertise. • <10% travel (limited to trainings, investigator meetings)

🏖️ Benefícios

• We are passionate about developing our people, through career development and progression • supportive and engaged line management • technical and therapeutic area training • peer recognition and total rewards program • We are committed to building an inclusive culture – where you can authentically be yourself.