Site Activation Manager assigned to ClientUpdated:YesterdayLocation:MEX-ClientJob ID: ********OverviewSite Activation Manager assigned to Client.This role oversees Site Start-Up (SSU) deliverables within the assigned projects, ensuring activation-ready sites are delivered on time and in compliance with applicable regulations.Job ResponsibilitiesResponsible 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.Oversees all Site Start-Up activities from site selection/recommendation through site-activation ready and all maintenance activities for the life cycle of the study.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.Provides mentoring and/or oversight of less experienced Site Activation Managers.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, interprets data on complex issues, makes good business decisions, and ensures solutions are implemented.Ensures all project deliverables meet internal and customer 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 from site selection through site activation and into 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 required amendments; Establishing and overseeing Essential Document collection leading to site activation; Overall SSU timelines, prior to and following site activation, including any realignment required due to amendment needs.Develops plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes.Ensures all controlled document requirements and other requirements to ensure quality deliverables.Develops and manages integrated site start-up timelines and reports weekly progress including plans to address potential timing risks/gaps.Prepares and presents overall SSU strategy and status at client meetings and communicates outcomes to the 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.If out-of-scope work is requested, notifies the PM and SSU Manager and tracks out-of-scope work until it is assigned to backlog.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.Responsible for or assists in initial or amendment updated development of master Subject Information Sheet (SIS) /Informed Consent Form (ICF) in collaboration with the PM and Medical Department.Oversees collation, quality review, and submission of country-specific applications.Contributes to change initiatives across and within the SSU department.Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.Performs other work-related duties as assigned.Minimal travel may be required (up to 25%).
Compliance and Equal OpportunitySyneos Health is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status.If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email:
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📌 Site Activation Manager Assigned To Client (Tlalnepantla de Baz)
🏢 Syneos Health
📍 Tlalnepantla de Baz