Country and Study Start-up Specialist - Middle East
Localização Riyadh, Riade, Arábia Saudita Categoria Pesquisa e desenvolvimento Job Id 202410-126648
DESCRIÇÃO DE FUNÇÕES A Roche promove a diversidade, a equidade e a inclusão, representando as comunidades que atendemos. Ao lidar com saúde em escala global, a diversidade é um ingrediente essencial para o sucesso. Acreditamos que a inclusão é essencial para entender as diferentes necessidades de saúde. Juntos, abraçamos a individualidade e compartilhamos a paixão por cuidados excepcionais. Junte-se à Roche, onde cada voz é importante.
A posição
The Opportunity
Coordinates/supports and/or executes all operational aspects for implementation of clinical trial activities from study feasibility, start-up through database lock, ensuring Roche quality and safety standards, regulations, timelines and budget commitments are met.
Responsible for the negotiation of site budgets within Fair Market Value (FMV) guidelines, budget plans and provides oversight for site payments per contract, as required.
Manages/updates and performs quality review for shared study areas and systems according to Roche standards, and is responsible for audits/inspections.
Responsible for ordering study-related supplies and medical products.
Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures, and works with regulatory authorities on enhancing the governance ecosystem.
Prepares country and/or site Informed Consent Form (ICF) and clinical study documents which need translation from English into local language.
Prepares and translates country and/or site clinical study documents, and obtains ethics committees' and local regulatory authorities' approval.
Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities including safety submissions as needed within the country. Updates the relevant systems as required for tracking of the local IRBs/IECs and regulatory authorities activities.
Who you are:
University degree in a medical/science-related field.
Deep knowledge, understanding, and experience of clinical trials and ICH-GCP.
Monitoring experience is desirable.
Previous experience managing projects is desirable.
Availability to travel nationally and internationally, if required.
Ability to communicate clearly and accurately in both written and spoken English and Arabic.
Communication, Accountability, Adaptability, Building Partnerships, Team Work, Decision Making.
Quem nós somos
Na Roche 100,000 pessoas em 100 países estão ultrapassando as fronteiras em cuidados com a saúde. Trabalhando juntos, nos tornamos um dos líderes mundiais em grupos de pesquisas. Nosso sucesso é construído com inovação, curiosidade e diversidade.
A Roche é um empregador que pratica políticas de igualdade de oportunidades.
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