Pille Metsa

Background

About Pille Metsa

Since April 2017 working as a Global Regulatory Start-up/ Site Activation Manager -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 -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: Life Cycle maintenance regulatory activities (study maintenance and amendment submissions, oversight of communication to competent authorities/ethics committees, import/export license extensions) Oversight of delivery of executed amended clinical trial agreements and investigator budgets with investigator sites-Prepares and presents overall SSU strategy and status at client meetings and communicates outcomes to project team-Reviews the project SSU budget, takes corrective measures where necessary to keep projects in line with budget and gross profit expectations-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-Assists in 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.