Omnia Aboutaleb Email & Phone Number

Giza, Al Jizah, Egypt

Egypt

• Act in the capacity of project manager for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. • Serve as the Medical Writing representative on assigned project teams, providing proactive support to CDM for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.• Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.• Ensure document content and style adheres to ICH/FDA/EMEA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.• Coordinate production and distribution of draft and final documents to DOM and client. Ensure that all work is complete and of high quality prior to team distribution or shipment to client.• Perform literature searches/reviews as necessary to obtain background information and training for development of documents.• Review statistical analysis plans to assist in determining appropriateness of content/format for clinical writing.• Provide training and guidance and act as a mentor to less experienced departmental members.• Assist management as needed with preparation of resourcing estimates for potential new medical writing projects.• Assist management as needed in reviewing request for proposal packages sent by clients to determine content and appropriateness of materials required for development of clinical documents.• Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures.• Assist in the development of departmental SOPs.

Egypt

1. Take an active part in internal and client's meetings as applicable.2. CRF design.3. Liaise with IT programmer at the stage of database design.4. Liaise with Biostatistician at the stage of data base design for data tables' purposes.5. Responsible for identification the needs assessment of each project delivered to Clinart MENA to start training the staff of data entry by its new CRF design.6. Writes and/or review clinical trial documentation including the data management plan.7. Assign; train; and manage the team of data entry staff.8. Monitor the quality of data entry.9. Conduct database audits according to established SOPs including data entry, comparison and verification.10. Query processing, including creation and resolution of routine and complex queries.11. Project management for CDM tasks for clinical trials12. Manage CDM activities for outsourced studies13. Ensures that incoming CRFs are tracked in a timely manner14. Safety review upon manual review.16. Actively participate in Clinart MENA training programs.

• Build, test and validate database.• CRF annotation.• DB specifications, development and validation.• Line listings review, including safety and/or safety review.• Prepare and perform SAE reconciliation.• Lab data management.• Discrepancies and query management and tracking.• Identify and report protocol violations.• Manual and Patient Profile review, issue queries.• Perform early and final database QC activities.• Coordinate CRF design.• Develop and execute SOPs, departmental guidelines and data standards to guarantee database quality control and data management compliance.• Document, verify, validate and execute regulatory compliant programs to perform clinical data management activities.• Guarantee that user acceptance testing, data transfer requirements and deployment of clinical trial sites are well defined.• Manage and track CRF flow and scanning and input required data.• Enter and compile data to generate and develop summary reports and graphics.• Meet client and business needs to have all projects optimally resourced with suitably experienced staff.• Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan.• Provide consultation, facilitate metrics collection and develop action plans in conjunction with Management to keep project on time and within budget.• Perform audit for project not assigned. Generate and provide feedback on project related audit.• Represent Operations Quality Management in audits and inspections as required.• Prepare and submit daily activities report to facilitate and enhance company KPls.• Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and DataClin SOPs.• Provide study specific training to other team members.• Respect of Company's Values, and Code of Ethics.

• Use specific coding tools - MedDRA, WHO drug dictionary and other recognized pharmacopoeia to ensure correctness of coding.• Write clear and concise queries for coding clarification.• Identify the need of study specific coding conventions.• Create and maintain study specific coding conventions when required.• Adhere to client specific coding conventions, if any.• Assist and support clinical data managers in order to identify the specific coded panels and dictionaries / versions to be used.• Coordinate with clinical data managers regarding timing of import / exports of data to the client.• Review coding listings to ensure accuracy and consistency of coded data.• Provide coding listings for client review, action and integrate client's feedback / comments, if any.• Assist Clinical Data Managers with SAE reconciliation of coded terms according to established guidelines.• Liaise and coordinate coding activities with the Clinical data managers to ensure optimum harmonization in order to respect the study timelines.• Represent the Coding group within the clinical study team and liaise with clients.• Participate in internal project team meetings and facilitate efficient project communication.• Participate in database lock process and snapshots and ensures that all coding steps prior to locking the database are complete.• Maintain coding specific project files.• Maintain up-to-date knowledge of changes in coding dictionaries or coding processes – eg: MedDRA, WHO drug dictionary.• Provide support for Coding process improvement.• Respect of Company's Values, and Code of Ethics.

• Track and receipt paper CRF.• Perform DE as per study specific convention.• Transcription, entry and verification of clinical trials source data into case report forms of various formats.• Interface with other department personnel on all transcription and/or data entry issues.• Assistance in performing quality control.• Provide technical support to assigned projects for example download, copy and keeping records of all electronic data.• Assist with record keeping, quality control and filling of study documents according to DataClin SOPs.• Create Central Files for new studies and maintain Central Files for ongoing studies according to DataClin SOP's or contractual obligation to sponsor.• Track, scan, code, file and retrieve documents as required for project team members.• Complete routine administrative tasks in a timely manner Photocopy, print and distribute documents, as needed.• Enter clinical trial data into the appropriate database.• Ensure up to date study documents in tracking systems.• Develop study related plans in coordination with CDM.• Maintain quality control procedures to ensure accurate maintenance of files.• Develop CRF annotation according to CDASH standards.• Develop/review project plans, including data entry conventions, data management plan, data validation plan, QC plan.• Develop database entry screens, perform test.• Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and DataClin SOP and study specific procedure.