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Local Clinical Operations Manager

Detalles de la oferta

.**Company Description****Job Description** Purpose Statement**:- Collaborate with the coordination of planning, implementation, and conduction of local and global clinical studies (Post-Marketing Observational, Multi-Country Non-Interventional, Investigator Initiated, Non-AbbVie Sponsored Collaborative and Pharmacoeconomic) and Pre-Approval Access programs (PAAs) according to Abbvie business strategy across Mexico.- Manage the activities of clinical investigation across multiple protocols of RWE and multiple therapeutic areas. Conduct these activities in accordance with federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, Abbvie policies and Standard Operating Procedures (SOPs) and business processes.- Collaborate with the coordination of planning, implementation, and conduction of local publications across Mexico.**Major Responsibilities**:- Ensure the execution for Post Marketing Observational Studies (PMSO) in accordance with all relevant processes, procedures & applicable SOPs and Local regulations; making certain that data is delivered within the agreed parameters (quality/time).- Establish evidence governance in collaboration with Market Access to develop local long-term evidence strategies implemented through tailored research plans.- Prepares CA (Competent Authority) and/or EC (Ethic Committee) documentation, ensures submissions and/or notifications are performed as applicable. Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up.- Customize and execute agreements, consent and assent forms, local monitoring plan and other documents for evidence generation projects.- Participate in the development of protocol and synopsis for evidence generation projects.- Actively participate in the amendment of all the required documents of evidence generation projects.- Identify, evaluate and recommend new/potential investigators/sites on an ongoing basis.- Participate in the selection process of investigation sites and principal investigators, ensuring the engagement of physicians and institutions of high scientific relevance and in accordance with the corporate strategy.- Plan, prepare and conduct study site personnel on the protocol and applicable regulatory requirements.- Proactively identify issues that may impact enrollment and recruitment timelines. Anticipates and identifies site issues that could affect Clinical Studies timelines and collaborate in developing alternative solutions. Collaborate with senior staff to develop initiatives and contingencies to ensure that timelines are met.- Manage projects according to budget and report progress to budget.- Anticipate potential problems within a study and create contingency plan accordingly.- Review and approve monitoring visit reports and enrollment updates when required.- Ensures the management and tracking of all regulatory documents.- Lead the process of scientific publications in the affiliate


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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