Affiliate Manager

• Site start-up and activation
• Deploys client site strategies by qualifying and activating assigned sites
• Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list and provide site qualification output for site selection
• Collaborates with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country Standard of Care (SOC) and medical practices (as applicable) under supervision
• Maintains a knowledge of assigned protocols
• Conducts study start-up activities at the site level including but not limited to Site Qualification, coordination of site activation checklist items, Informed Consent Form (ICF) finalization, Site Initiation Visit (SIV) as applicable, including management of issues that may compromise time to site activation
• Ensures all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation
• Supports country specific ICF review and deployment up to Site Activation
• Ensures follow up activities’ completion post Site qualification visit and SIV to ensure site readiness for First Subject First Visit (FSFV)
• Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness in anticipation of FSFV
• Responsible for relationship building and operational quality of the site
• Provides study support on escalated site issues related to study delivery by coordinating communications and resolution efforts.
• Ensures the strategy and approach for Investigational Product (IP) and ancillary supplies for sites and country requirement throughout the lifecycle of the study
• Accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Jointly responsible with CRA for enrollment delivery during study conduct
• Partners with local Regulatory authorities and Study Start up teams to ensure timely completion on country / local registry up to Site Activation
• Provides input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics
• Provides support to study management to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies
• Reviews Site Reports and related issues
• Assures quality and consistency in the delivery of monitoring
• Supports the CRA to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Study Management
• Complies with required training curriculum

Site Care Partner – FSP

Global Head of Partner Network

Head of Supplier and Product Enablement