Silvana William

Experience

• 

  Marketeers

  Aug 2012 - Oct 2012

  Market Researcher

  Market research Analyst at the operation department with the following responsibilities:- Perform market research.- Determine who will buy products and at what price.- Advise on pricing strategies.- Gather statistical data on competitors.- Examine prices, methods of marketing, and sales.- Conduct surveys.

• 

  Cairo English School

  Oct 2012 - May 2013

  Teacher Assistant

  Teacher assistant for Grade 5 with the following responsibilities:- Supporting pupils with learning difficulties.- Preparing the classroom for lessons.- Creating displays of pupils’ work.

• 

  Roche Egypt LLC

  May 2013 - Aug 2015

  Assigned as a Lead Monitor in many clinical trials with the following responsibilities.- Monitor the conduct of the clinical trials according to Roche SOP's and the International Congress on harmonization – Good Clinical Practice (ICH-GCP) guidelines.- Study start up activities of 2 studies. - Handling 5 Feasibility of studies of different phases .- 75 monitoring visits and performing site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.- Develop and monitor study budget and timelines.- Handling 95 Submission Package to the ethics committee, which safeguards the rights, safety and well being of all trial subjects and managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs.- Identifying/selecting an investigator who will be responsible for the conduct of the trial.- Setting up the trial sites, which includes ensuring each center has the trial materials, including the trial drug (IMP). Plus training the site staff to trial-specific industry standards.- Verifying that data entered on to the CRFs is consistent with patient clinical notes, source data/document verification (SDV).- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead CTL.- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation. Show less - Coordinate all information and communications for assigned projects.- Create a detailed work plan which identifies and sequences the activities needed to successfully complete the project.- Update and maintain internal databases, tracking systems and project plans with project specific information.- Determine the resources (time, money, equipment, etc) required to complete the project.- Participate in the conduct of GCP workshops for physicians and potential investigators.- Coordinating logistics of the first Clinical Research Center in Ain-Shams University.- Participate in conducting the first GCP training rounds in Ain-Shams University at the International Annual Ain-Shams Medical Congress with 78 Investigators attended.- Planning of the first Electronic IRB in Egypt at National Cancer Institute.- Upgrading the IMP room and Archive room of Clinical Research Center of Kasr Al-Aini Hospital.- Clinical Research Unit Site Assessment: • Ain-Shams University-Oncology Department. • El-Matareya Educational Hospital-Oncology Department. • Kasr Al Aini Hospital- Oncology Department. Show less

  • Clinical Research Associate

    May 2013 - Aug 2015

  • Clinical Research Associate

    May 2013 - Aug 2015
• 

  IQVIA

  Sept 2015 - Sept 2021

  Job Family DescriptionAssists businesses and other organizations to operate more efficiently by identifying and measuring problems, and recommending, customizing and implementing solutions surrounding management, technology, strategy and clinical life sciences.Sub-Family Description Delivers high quality, on-time deliverables to client projects in the life sciences field. May have broad knowledge of several industries and/or broad experience within a specialty area (i.e., life sciences, management, data, technology, analytics, performance management, etc.). Redesign business processes and new business processes. Performs quantitative or qualitative analysis to identify client issues.Reviews and analyzes client requirements and develops insightful, value add proposals; communicates with clients; develops and may present complete client-specific solutions and recommendations. Creates client reports. Connects business problems to proper solutions and offerings. Primarily project focused and solution driven. Develops and/or elevates new business opportunities through the identification of follow-on work and new leads. Provides follow-up with client after project deliverables are complete to ensure client satisfaction. May possess elements of strategic consulting however not primary focus. Implements intiatives into business operations. Coaches/mentors teams; business development and contributes to driving thought leadership. Show less • Ensure overall project efficiency and adherence to project timelines and financial goals; report metrics and out of scope activities.• Act as the first line of escalation for site management questions and issues for assigned projects.• Make sure project resourcing for CRA/SM is in line with expectations• For selected studies, participates in the site/investigator selection system/process• Coordinates sites including start-up activities, covering all countries for the selected study• Tracks all Ethic Approvals and all CRA activities• Reviews protocol and assists with case report form design• Develops study monitoring plans for assigned studies• Documents site-specific monitoring visit plans and reports• For selected studies, participates in completion of study related documents, including informed consent form, template source documents, training manuals, regulatory binder and other resource materials• Assists with IRB/ethic committee submission process (both central and local submissions)• Assists in investigator and study staff training, including global CRA contractors when needed• Tracks and reports study site progress• Collaborates with the Site Management Team to provide centralized site support, communication and coordination, to assure accurate and timely completion of all contracted activities• Establishes and maintains communication with Clinical Research Associates and Site Managers• For selected studies, acts as Site Management Lead, by coordinating resources, trainings and CRA activities among a team of Site Managers and CRAs Show less - Manage the operational aspects of projects to achieve “right subjects” and “right data” to meet contractual requirements. - Participate in bid defense preparations. Attend and present at bid defense presentations in partnership with business development and senior project leader as needed. - Develop, provide input, and maintain clinical project plans, including but not limited to clinical operations plan, recruitment and retention strategy plan, etc. to be incorporated into the integrated study management plan/project management plan. - Accountable for the clinical delivery (subject recruitment, site management, data integrity) of assigned portion of clinical studies, or may be fully accountable for less complex studies per contract, ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures. - Partner with the project leaders to confirm objectives of the clinical team according to agreed-upon contract, strategy and approach. Effectively communicate and assess performance against these agreed objectives. - Ensure or support ensuring, on less complex studies, that all appropriate subject/patient recruitment strategies are in place at the outset of the study to maximize subject/patient recruitment opportunities to achieve delivery according to contract, including, but not limited to, all outreach or digital offerings being explored and deployed.- Ensure all processes and tools are available to maximize clinical team’s ability to monitor and secure patient recruitment to the monitoring team from the outset of the study including, but not limited to a clear recruitment strategy plan, the subject/patient pathway materials and clearly defined contingency plans with agreed trigger points for deployment. Show less - Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.- Provide monitoring visits and site management for a variety of protocols, sites, therapeutic areas and study phases from Phase (II-IV).- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.- Act as a mentor for clinical staff including conducting co-monitoring and training visits.- May provide assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes. Show less Working as Clinical Research Associate for Pharma Development Studies with the following responsibilities: - Coordinate the movement of laboratory samples and the resulting data when central laboratory facilities are used.- Ensure procedures are in place for appropriate optimization of patients into the clinical trial.- Monitoring the assigned clinical trial following company SOPs and in accordance with GCP.- Be the point of first contact when investigators/site personnel inquire about patient inclusion/exclusion criteria for ongoing trials.- Participate in global conference calls and meetings to review progress of ongoing clinical trials.- Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion.- Manage patient recruitment strategies to increase patient randomization into the trial (eg investigator and research nurse meetings, update newsletters, advertising, letters to GPs).- Review all SAEs, ensure Medical Director sign-off, that sites are notified and that all company procedures are complied with.- Maintain project files including: ethics committee approvals; curriculum vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment. Show less

  • RWE Sr.Consultant/Clinical Project Manager

    Oct 2020 - Sept 2021

  • Associate Global Real Word Evidence Site Managment Lead

    Jul 2019 - Oct 2020

  • Global Clinical Project Lead Assigment

    May 2018 - Jul 2019

  • Senior Clinical Research Associate II

    Mar 2017 - Jul 2019

  • Clinical Research Associate

    Sept 2015 - Mar 2017
• 

  Syneos Health

  Sept 2021 - now

  Global Project Manager II - Project Management

  Project Leadership and Delivery: Manages a project as a project manager overseeing interdisciplinary clinical research studies andensures compliance with GCP, relevant SOP’s, and regulatory requirements. Acts as a primary liaison between the Company and the Customer to ensure timely study launch,conduct, and closeout according to the Customer’s and the Company’s contractual agreement. Lead project team to ensure quality, timelines and budget management. Accountable for the financial performance of each project. Coordinate activities and deliverables of all study conduct partners and proactively identify andmanage issues. Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatoryrequirements. Accountable for all project deliverables for each project assigned.Documentation and Reporting: Responsible for quality and completeness of TMF for assigned projects. Accountable for maintenance of study information on a variety of databases and systems. Responsible for study management components of inspection readiness for all aspects of thestudy conduct. Oversight for development and implementation of project plans. Plan, coordinate and present at internal and external meetings. Prepare project management reports for clients and management. Show less