Site Activation Manager

Site Activation Manager (FSP) - Min 2 years of previous local regulatory experience in Mexico, English intermediate - Hybrid 2x3 CDMXSyneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.technical and therapeutic area training; Job ResponsibilitiesCollaborates 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 for the life cycle maintenance of projects.

Assumes accountability on start-up deliverables including but not limited to o Life Cycle maintenance regulatory activities (study maintenance and amendment submissions, oversight of communication to competent authorities/ethics committees, import/export license extensions) o Oversight of delivery of executed amended clinical trial agreements and investigator budgets with investigator sites.

Complies all controlled document requirements and other requirements to ensure quality deliverables.

Prepares/assists 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.

Project management experience in a fast-paced environment. Good vendor management skillsStrong 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 peersGet to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

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.
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