13. Responds to internal and external customers and clinicians involved with product-related complaints or concerns, specific to issues involving potential or real patient safety or device efficiency.
15. Enforces compliance with and Good Clinical Practice (GCP), local, Federal and International Regulatory requirements as applicable and required.
16. Under direction of the Clinical Management team coordinates data related activities with data management team including data review, verification, clarification and transmission.
17. Assists in the administration and control identification of shipment, use and return of non-sterile and sterile investigative products to key domestic and international investigational centers.
21. Periodic monitoring of protocol pager for urgent site/subject related issues. Responsibilities:<br />Project Coordinator<br />Clintec Int.<br />August 2007-March 2008<br />ClinTec International is a full service clinical research organization.<br />As Clinical Project Coordinator the main tasks were planning, coordinating, directing, providing customer care and evaluating daily operations and guiding the unit based team. Collaborating with staff and manager in the development of performance improvement initiatives that will effect network-wide operations. Involvement with various disciplines in the development and implementation of clinical practice guidelines and staff development.<br />Assist the Project Manager and Superintendent, where applicable, in the day to day duties of a project’s administration.<br />Working closely under the guidance and direction of the Project Manager <br />Assist in plan and spec analysis in order to provide clear, trackable and coordinated interpretations of the design/drawings for construction.<br />Research and recommend solutions to design document problems, including conflicts, interferences and errors/omissions.<br />Act as liaison with subcontractors in expediting drawings and related information.<br />Maintain accurate and up-to-date logs (RFI, Vendor/Subcontractor, Purchase, and Owner etc.), track responses and advice the Project Manager and Superintendent of the status of RFIs.<br />Obtain quotations for Notices of Change.<br />Maintain and update the Shop Drawing Log, review Shop Drawings and submittals.<br />Coordinate submittals and procure all close-out documents including warranties and Operating and Maintenance Manuals.<br />Monitor field work, including contract work, to ensure compliance with company standards, procedures, specifications and codes.<br />Participate in the continuous updating and accurate generation of as-built documents.<br />Assist with the research and preparation of field change requests to resolve design issues. Conduct quality control activities in accordance with instructions, inspection programs, using specified control measuring and testing equipment.<br />Prepare drawings and sketches to support construction work as required.<br />Understand and perform document control functions in accordance with on-site policy and procedures, including tracking and creating of RFIs, transmitting and tracking of submittals, compose agreements, and maintain project expediting list.<br />Attend project coordination and owner/contractor/architect/engineer meetings as requested or required.<br />Coordinate periodic job-related photographs for records.<br />Present oneself as a candidate for promotion by learning and understanding construction methods and developing good construction management skills.<br />Perform additional assignments and responsibilities as assumed or requested by supervision.<br />Worked as consultant in the past 16 years for the largest Pharmaceutical companies: Sanofi Synthelabo, Boehringer Ingelheim, Chiron, Yamanouchi and<br /> Merck.<br />EDUCATION<br />M.Sc.Medical Biology<br />Free University AmsterdamAmsterdam, the Netherlands<br />1992 - 1998<br />BSc.International Law<br />Leiden University, the Netherlands (ongoing)<br />Msc.Life Science & Technology<br />Technische Universiteit Delft, the Netherlands (ongoing)<br />TECHNICAL/EDC EXPERIENCE<br />Microsoft Word, Microsoft Outlook, Microsoft Projects, Inform, Medidata, etrials<br />Core Competencies:<br />Clinical Research Project management • Solution Design • Global Network • Project Management • Staff Leadership • Client Relationship Management • Change Management • Operations Management<br />ADDITIONAL TRAINING<br />Risk Management Project Management, February 2010<br />ICH/GCP Guidelines Review and Updates, February 2010<br />SAE Report and Guidelines <Association, February 2010<br />
![Edith Ramroochsingh<br />PoBox 186<br />2150 AD Nw-vennep<br />Ph.: 1 954 990 0043<br />Cell: 31 6 46 228087<br />edithramroochsingh@gmail.com<br />Summary<br />An experienced Biotechnology Professional with strong entrepreneurial skills for last 16 years as well versed in operating at a Board level and Corporate Governance, adept at strategy formulation and risk management. Strong Performance management skills acquired in a multi-national, multi-product environment and experienced in LifeScience & Biotechnology Fund raising & investor relations. Heavy change management experience with a demonstrated ability to articulate vision, execute plans, deliver goals and motivate teams. Highly qualified skills in the Project management of Clinical Drug Development.<br />THERAPEUTIC EXPERIENCE<br />,[object Object]](https://image.slidesharecdn.com/resumeedithramroochsingh-12859786033939-phpapp01/85/Resume-Edith-Ramroochsingh-1-320.jpg)
