Nadia Miltoni - Team leader,

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Work Background

IDDI - Biostatistics & eClinical ExpertsTeam Leader Clinical Data Reviewer

Nov. 2022United States• Supervise the Global CDR activities and individuals: personnel issues, planning, training, coaching, recruitment, performance reviews, and career development • Together with the Director, CDM recruit new staff members in EU and/or US in accordance with the department workload • Ensure the training plan for new employees is always up-to-date and ensure their coaching. • Ensure that all activities performed by the team are covered by a Standard Operating Procedure (SOP), and lead the development of new SOPs when applicable • Organize team meetings and act as the CDR representative in the other CDM sub-teams meetings when required • Ensure the work performed by the team is in accordance with IDDI SOPs. • Perform all activities of a CDR.

IDDI - Biostatistics & eClinical ExpertsTeam Leader CDQA specialist

Jun. 2020 - Nov. 2022Raleigh, North Carolina, United States

IDDI - Biostatistics & eClinical ExpertsCDQA specialist

Nov. 2016 - Jun. 2020Raleigh, North Carolina

UCBClinical Data Manager

Jan. 2009 - Aug. 2016Raleigh-Durham, North Carolina AreaPerforms project lead role duties that includes allocating and prioritizing workloads for multiple projects (media control, data entry, pre entry review and query management tasks), as needed. Complete pre-entry review of Case Report Forms (CRFs). Conduct Electronic Validations of clinical data. Generate Data Clarification Forms (DCFs). Review, research and resolve data entry flags. Update clinical database. Create/review CDM specification documents. Participate in CDM system validations. Complete various quality control activities. Complete database lock activities. Note : Still working on creating Submission Ready CRFs Quality control Training of the personnel

UCBLead Data Review and Submission processing

Sep. 2007 - Dec. 2008Greater Atlanta Area• Recruit, manage, coach, develop, and coordinate both contract and UCB resources to ensure project deliverables are achieved. Forecast study timelines to ensure data cleaning deliverables are achieved if performed in-house. Coordinate the assignment of resources and projects across the data review and submission processing teams. • Integrate Clinical Data Services sites (Atlanta, RTP and Monheim) in terms of team spirit, work style, used processes and technology in order to allow flexibility and smooth and quick workload balancing on a global level and as business necessitates. • Lead, mentor, coach, and develop all members in respective team. • Develop manpower estimation algorithms and associated staffing plans, in order to achieve efficiencies with effective management of resources. Maintain data cleaning and submission processing performance metrics for status reporting purposes, as well as determining additional resource needs. • Establish global standard procedures and guidelines for activities surrounding data cleaning and submission processing. • Participate in system validation processes, ensuring appropriate resource allocation for test script creation, execution and document preparation. • Oversee the organization and preparation of high quality electronic documents for submission to regulatory agencies in an efficient and timely manner. Ensure the quality, integrity and timeliness of bookmarked and hyperlinked scanned CRFs to regulatory authorities (i.e. FDA). Develop and implement standard processes and planning for the generation of these electronic documents. • Participate in global and local Clinical Data Management initiatives, providing expertise regarding data review and submission processing in an effort to contribute to the continuous improvement of the processes and technologies utilized within the department. • Ensure adherence to federal regulations, GCP, GCDMP,UCB Standard Operating Procedures and working instructions.

UCBSenior Data Reviewer

Jan. 2006 - Jul. 2008Greater Atlanta Area• Mentoring and training junior level Clinical Data Associates in data cleaning activities. • Creating and reviewing test patient data, based on the Data Cleaning Plan, to establish documented evidence which provides a high degree of assurance that the clinical programming meets the required specification. • Reviewing and interpreting data discrepancy output, as well as performing manual listing reviews and generating data queries to be sent to the investigational site. • Interpreting data cleaning specifications, creating/troubleshooting clinical data ensuring the validation of the programming, and managing the data cleaning process for a study. • Interpreting/troubleshooting test patient data to ensure the accuracy of the programming of the validation checks. • Interpreting clinical site investigator responses to queries on the data and making appropriate judgment as to whether the responses are sufficient. • Updating the clinical database with the resolution provided and determining the resolution status of the queries in the Discrepancy Management System. • Communicating with the investigational sites regarding data cleaning activities and query resolution. • Maintaining the Exceptions Report detailing anomalies, previously addressed, which result in no change to the clinical database. • Maintaining metrics and providing regular status update reports to the Clinical Data Manager and Clinical Study Team regarding data cleaning efforts in order to facilitate an expeditious database lock. • Assisting in the creation of PDDM, identifying protocol deviations to be discussed during the Pre Analysis review of data. • Performing quality control measures to ensure the final clinical database prepared for analysis and reporting is within the confidence level specified in the Data Management Plan. • Participating in global and local Clinical Data Management initiatives providing expertise regarding Discrepancy Management.

UCBCoding Specialist

Jan. 2005 - Dec. 2005Belgium• Ensuring Global Medical Coding of Term using Dictionary MedDRA and WHO-Drug • Validation and training of new tools • Drafting Coding Convention

UCBSenior Data Reviewer

Sep. 2003 - Dec. 2005Belgium

UCBPrincipal Data Entry Operator

Mar. 2002 - Dec. 2003Belgium

UCBData Entry Operator

Nov. 2001 - Mar. 2002Brussels Area, Belgium