Edith Ramroochsingh<br />PoBox 186<br />2150 AD Nw-vennep<br />Ph.: 1 954 990 0043<br />Cell: 31 6 46 228087<br />firstname.lastname@example.org<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 /><ul><li>Cardiovascular: Congestive Heart Failure, Coronary Artery Disease, and Hypertension
Respiratory: Chronic Obstructive Pulmonary Disorder, Asthma</li></ul>Experience as Study Coordinator:<br />Breast Cancer, Prostate Cancer, Melanoma, Non Small Cell Lung Cancer, Congestive Heart Failure, Coronary Artery Disease, Hypertension.<br />Experience as Sen. Clinical Research Associate/Lead Clinical Trial Coordinator:<br />developing and writing trial protocols (outlining the purpose and methodology of a trial);<br />presenting trial protocols to a steering committee;<br />designing data collection forms, known as case record forms (CRFs);<br />coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects; <br />managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs; <br />locating and assessing the suitability of facilities at a study centre;<br />liaising with doctors/consultants (or investigators) on conducting the trial;<br />setting up the study centers, which includes ensuring each centre has the trial materials and training site staff to trial-specific industry standards;<br />training site staff to industry standards;<br />monitoring the trial throughout its duration, which involves visiting the study centers on a regular basis;<br />verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV);<br />collecting completed CRFs from hospitals and general practices;<br />writing visit reports;<br />filing and collating trial documentation and reports;<br />ensuring all unused trial supplies are accounted for; <br />closing down study centers on completion of the trial;<br />discussing results with a medical statistician, who usually writes technical trial reports;<br />archiving study documentation and correspondence;<br />preparing final reports and occasionally manuscripts for publication.<br /> <br />Phases of Experience: Phase I – III<br />PROFESSIONAL EXPERIENCE<br />Global Clinical ServicesNieuw-vennep Noord-Holland<br />Date April 2008- Present Ad-interim Consultant for below-mentioned companies:<br />Global Clinical Services BV is providing outsourced Pharmaceutical Services to the LifeScience and Biotechnology companies.<br />Sen. Clinical Project Manager<br />Genzyme BVAlmereNoord-Holland<br />Feb 2010- April 2010<br />Genzyme is a Biotechnology company. <br />Senior Project Managers role with 6-8+ years experience managing large-scale interactive projects from discovery and design to technical development and implementation. Extensive experience in an agency environment working with and implementing both project management and online best practices on and across large-scale engagements are a critical component of this role.<br />Responsibilities:<br />Responsible for developing overall project management strategy and working with discipline leads and project teams to execute on plans <br />Monitor day-to-day activities of the project team and ensure work is progressing as planned. Work with project team and actively be involved in the work <br />Manage schedules, budgets, assets, and overall project organization to ensure requirements and project deliverables dates are clearly communicated, understood and executed upon. <br />Ability to work across several projects with one or more junior project manager(s) or as the primary Project Manager on a large-scale engagement <br />Effectively and efficiently plan and prioritize all deliverables and resources working across project(s) based on scope of work and project goals <br />Actively monitor project risks and scope creep to foresee/identify potential problems and proactively identify solutions to address them in advance <br />Consistently identify needs that Clients may not recognize and ensure approaches and solutions are linked to objectives and future needs <br />Consistently manage client expectations, ensure delivery of the highest quality service, and solicit and act on client feedback <br />Communicate and document project status and strategic recommendations to clients, team members and senior management on a regular basis; escalate issues accordingly via the appropriate channels <br />Proactively identify opportunities and deliver improvements; evangelize the project management methodology and project processes <br />Partner with project team leads to present work as well as participate in new business presentation opportunities <br />Lead the training/mentoring of junior project managers on project management methodologies and best practices as required <br />Sen. Clinical Research Associate<br />Pharm-Olam <br />October 2008- Feb2009 <br />Pharm-Olam is a full service clinical research organization.<br />Participate in the trial, set up activities and site selection and manage investigational sites in Benelux ensuring compliance with SOPs and GCP. Preparation, translation, review and completion of study documents and Ensure accuracy, validity and completeness of data collected at the investigational sites. Prepare and participate actively in investigators meetings Conductance and report monitoring visits as well maintain regular contacts with the sponsor, investigator and project manager. Organization of regular meetings with project team.<br /><ul><li>Works with a multi-disciplinary team to identify key clinical centers and affiliated collaborators for implementation of formal clinical studies of new products and/or new product indications.
May participate in study development and start-up process including development and review of study related tools.
Organizes, monitors, implements, and reports on clinical studies necessary for marketing approval via regulatory agencies.
Collects, reviews, verifies and summarizes patient data from study sites.
Oversees Contract/Regional Clinical Monitors, with supervision and reports progress and/or risk to Clinical Management/Program Manager.
Troubleshoots and resolves routine study conduct issues and routine data related issues
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.
Enforces compliance of Clinical Procedures and SOPs.
Enforces compliance with and Good Clinical Practice (GCP), local, Federal and International Regulatory requirements as applicable and required.
Under direction of the Clinical Management team coordinates data related activities with data management team including data review, verification, clarification and transmission.
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.
Creates and maintains patient, study and regulatory files and status reports.
Travels to clinical sites to initiate, monitor compliance and perform closeout visits for clinical studies.
Primary Contact for study sites for study related questions.
Periodic monitoring of protocol pager for urgent site/subject related issues. </li></ul>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 />