Job summary This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready. Responsibilities include, but are not limited to: - Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). - Oversees and tracks clinical research-related payments. Payment reconciliation at study closeout. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with Sr.COM /other roles. - Executes and oversees clinical trial country submissions and approvals for assigned protocols. - Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols. Collaborates closely with Headquarter to align country timelines for assigned protocols. - Provide support and oversight to local vendors as applicable. - Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems. Core competencies: - Expertise of core clinical systems, tools and metrics - Excellent verbal and written influencing and training/mentoring skills, in local language and English - Strong coordination and organizational skills - Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up. Behavioral Competency Expectations: - Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. - Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills. - High sense of accountability and urgency in order to properly prioritize deliverables - Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English. Descripción del trabajo Lorem ipsum dolor sit amet , consectetur adipiscing elit. Nullam tempor vestibulum ex, eget consequat quam pellentesque vel. Etiam congue sed elit nec elementum. Morbi diam metus, rutrum id eleifend ac, porta in lectus. Sed scelerisque a augue et ornare. Donec lacinia nisi nec odio ultricies imperdiet. Morbi a dolor dignissim, tristique enim et, semper lacus. Morbi laoreet sollicitudin justo eget eleifend. Donec felis augue, accumsan in dapibus a, mattis sed ligula. Vestibulum at aliquet erat. Curabitur rhoncus urna vitae quam suscipit , at pulvinar turpis lacinia. Mauris magna sem, dignissim finibus fermentum ac, placerat at ex. Pellentesque aliquet, lorem pulvinar mollis ornare, orci turpis fermentum urna, non ullamcorper ligula enim a ante. Duis dolor est, consectetur ut sapien lacinia, tempor condimentum purus. Obtén acceso completo Accede a todos los puestos de alto nivel y consigue el trabajo de tus sueños. Inscríbete ahora