Descripción de la oferta
Global Site Activation Manager in LATAM - Min 3/4 years of previous exp as site activation lead with global scope in CRO We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; Responsible and accountable for the customer-focused leadership and management of Site Start-Up (SSU) deliverables within a country, region or globally, within the assigned projects or programs. Directs the technical and operational aspects of the Site Start-Up deliverables of the assigned projects. Accountable for the delivery of activation-ready study sites on time, on budget, and in compliance with all applicable regulations. Develops SSU timelines as required and reports progress including plans to address potential risks/gaps to the project team, Project Manager (PM), SSU Management and Project Sponsor. Collaborates with major functional areas including, but not limited to: Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing. Identifies and evaluates fundamental issues pertaining to Site Start-Up, project regulatory pathway, successful patient enrollment, interpret data on complex issues, make good business decisions, and ensure solutions are implemented. Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk identification, mitigation and management. Develops and maintains relationships with customers in alignment with their assigned projects. Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed. Provides oversight of all project start-up deliverables which encompasses all activities from site selection through site activation ready and into the life cycle maintenance of projects. Assumes accountability on start-up deliverables including, but not limited to: Site Identification and selection, Start-up and life cycle maintenance regulatory activities (submissions, oversight of communication to competent authorities/ethics committees, import/export licenses and extensions, study maintenance and amendment submissions), Oversight of delivery of executed clinical trial agreements and investigator budgets with investigator sites, including any require amendments, Establishing and overseeing Essential Document collection leading to site activation, Overall SSU timelines, prior to and following site activation. Complies all controlled document requirements and other requirements to ensure quality deliverables. Prepares and presents overall SSU strategy and status at client meetings and communicates outcomes to project team. Reviews the project SSU budget with the functional leads, PM, and the SSU Business Unit Controller against project milestones and budget to ensure project profitability. Takes corrective measures where necessary to keep projects in line with budget and gross profit expectations. Uses professionally recognized tools for planning and management of scope, timeline, and resources and ensures effective budget management. Prepares the core submission documents and core clinical trial application dossier for amendments during life cycle maintenance of the projects. Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/Project teams and oversees review for Regulatory Impact Assessment for 2nd level to identify gaps, highlights any risk management to Sponsor/Project teams. Oversees collation, quality review, and submission of country-specific applications. Bachelor’s Degree, Higher Degree Preferred. English advanced. Project management experience in a fast-paced environment. Good vendor management skills Strong organizational skills with proven ability to handle multiple projects. Quality-driven in all managed activities. Demonstrate an ability to provide quality feedback and guidance to peers. Further, nothing contained herein should be construed to create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. #
