Chiara Saletti Email and Phone Number

•Leadership role with the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s). Gather content and integration requirements for eCRF and other data collection tools.•Establish conventions and quality expectations for clinical data. •Set timelines and follow-up regularly to ensure delivery of all Data Management milestones. •Performs trial level oversight controls •Review clinical data management documents ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency.•Ensure compliance with regulatory guidelines•Ensure real-time inspection readiness of all Data Management deliverables for the trial; •Helps plan and track content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.

• Fully responsible for all data management tasks, including management of timelines and resources; • Supports and drives the client in the definition of the best approaches and solutions to be applied in the studies; • Works closely with Project management, to identify risks and opportunities; • Primary point of contact for all clinical activities; • Study database setup and testing, All Data Cleaning Processes and Data Reconciliation (SAS System); • Study closure, Final Database Locks and release to Statistical Analysis • Monitors progress of activities in the study, also producing data progress reports and metrics, sharing information and promptly escalating eventual issues within the study team; • Project Plan and RFP revision;• Effectively contribute in formal training for new starters; • Effectively represents Data Management in internal or external meetings (e.g. Investigators Meetings):• Make recommendations for process improvements and development of new standards;• Demonstrate broad and integrated knowledge of all aspects of Data Management providing consultancy to other groups outside CDM;• Proven ability to analyses data capture problems/opportunities and a track record of developing and delivering high quality solutions• Demonstrate good application of document management process and procedures;• Develop and maintain a network of contacts within the study team;• Works according to SOPs and guidance documents as well as applicable industry standards like ICH, GCP

•Fully responsible for all data management tasks, including management of timelines and resources; • Supports and drives the client in the definition of the best approaches and solutions to be applied in the studies; • Works closely with Project management, to identify risks and opportunities; • Primary point of contact for all clinical activities; • Study database setup and testing, All Data Cleaning Processes and Data Reconciliation (SAS System); • Study closure, Final Database Locks and release to Statistical Analysis • Monitors progress of activities in the study, also producing data progress reports and metrics, sharing information and promptly escalating eventual issues within the study team; • Project Plan and RFP revision;• Effectively contribute in formal training for new starters;• Effectively represents Data Management in internal or external meetings (e.g. Investigators Meetings) • Works according to SOPs and guidance documents as well as applicable industry standards like ICH, GCP.

• Design the Case Record Form and guide process for CRF approval Define and develop the Data Management Plan, with input from study team;• Validation of the database and computerized checks, including SAS listings or SAS checks;• For EDC studies, define the User Acceptance Test Plan (UAT) and execute the test plan in the test environment to ensure quality eCRF;• Prepare study specific data-entry guidelines and train data-entry staff;• Input into and monitor progress against study project plan and escalate issues to resolution at the appropriate level;• Query Management: review answered queries resolve and close where appropriate, manage the data cleaning process;• Perform term cleaning for clinical studies, raise manual queries for un-coded terms, as required, review answered queries and close where appropriate;• Run and monitor study data progress reports including query management and take appropriate actions (e.g., escalation, re-training, etc.), escalate any study issues within study team;• Perform reconciliation of external data (could include SAE, Central Labs, ECGs etc);• Perform timely data integration of CRF and non CRF data (data import from external sources) Define & execute QC plan, execute database release and database freeze activities;• Apply SOPs and guidance documents as well as applicable industry standards like ICH, GCP etc..to day-to-day activities generation all the required documentation for study files;• Lead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling, and prioritizing.