• Over 5 years of experience working in CRO• Over 60 clinical studies of experience working in data management• Over 150 clinical studies of experience working in DM project management• Over 8 years of experience working in epidemiological survey and research• Over 15 years of experience working in data management and database maintenance in medicine and pharmacy industry
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DmpmIcon Plc 2011 - 2013• Manage the projects to ensure their objectives are met within budget, to agreed timeline and to high level of quality.• Manage a clinical data management group, including but not limited to resource planning, recruitment, performance evaluations and training.• Develop and foster sponsor relationships through effective project management and communication.• Participant in internal/external Quality Audits (QA) about Data Management and manage findings through resolution operationally.• As a Project Manager communicating with Biostatistics and Medical Writing when Clinical Operations is not a function provided by ICON.• Participant in the development, implementation and maintenance of guidelines and procedures(SOPs, training manuals, etc.) to facilitate the efficient performance of data management activities.• Lead the performance for coding, translation as appropriate, and connect with global coding group.• Lead the development for Quality Control (QC) of studies and update DM operations as appropriate.• Read, ensure understanding and adhere to the study protocol, contract and scope of work for all tasks during set-up, maintenance and close-out of the study.• Provide support into CRF design, protocol review, edit check specifications, data entry conventions, monitoring guidelines, and any other study related documents, as required.• Review the data management plan and study specification and data verification specification (DVS). • Key point of performance SAE reconciliation, medical review, listing review for studies.• Key point of the study team on day to day study data management.• Attend regular data management team meetings, both internal and with the sponsor • Attend and provide an update for data management services at cross-functional study team meeting both internally and with the sponsor• Actively participate in the development of departmental specific training courses and conduct instructor led training courses for data management staff. -
Manager, Data ManagementBeijing Kendlewits Medical Consulting Co., Ltd(Inc) Oct 2010 - Nov 2011Beijing• Utilize creativity to improve data quality assurance. Represent Data Management at internal/external Quality Audits (QA) and manage findings through resolution operationally.• Work with functional and study team leaders to determine and implement new process testing.• Compile and evaluate feedback received from those involved in assess success and failures of potential new processes. • Manages the development, maintenance, implementation and revision of all departmental SOPs, Controlled Forms, Guidelines, and tools needed to ensure staff efficiency. • Develop, maintain and implement a modular training program that supports defined process flow, industry compliance requirements, and department processes to educate and empower others to function independently in their jobs.• Conduct and document training required technical training of new employees, and all required staff as new or modified processes are implemented. • Serve as technical advisor to Clinical Data Associates as related to study tasks and department procedure. • Work with department management to individually assess and provide needed technical development to department employees. • Partner with Clinical Systems to maintain and/or evaluate software needs related to the Data management function. • Coding/review clinical terms identifying medical history, physical exam findings, diagnoses, adverse events, medications, and other clinical data terminology, as appropriate. • Perform/review DMP, DVP, Edict check, listing/Medical review,etc. • Management IWRS/IVRS: Interactive Web-based Response System for subject randomization and study drug monitoring, per user requirements to be outlined in a IWRS specification.• Response for project management to met within budget, to agreed timeline and to high level of quality.
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Manager Of Data Management DepartmentBeijing Dms Pharma Ltd.(Cro) Aug 2008 - Sep 2010Beijing• Responsible for Data management of all studies, including phaseⅠ-Ⅳand other research projects. • Ensure the data quality assurance and streamline processes.• Ensure DM staff adherence to SOPs and WPs.• Effectively direct the activities of the data management department, projects, and staff in a manner that ensures all functions, projects, and tasks are handled with the highest quality, on time, and within budget. • Direct the day-to-day management of the data management department in a manner consistent with SOPs, regulations, and DMS policies. • Ensure that the company objectives are met in the areas of customer satisfaction, quality, finance, resources, and timeliness. • Responsible for CRF design, review protocol. • Coding for adverse event, SAE with MedDRA, WHOart. • Management IWRS/IVRS. • Maintain and coordinate more than 100 clinical trial projects. • Lead and motivate personally a group to operate day-to-day data management tasks, which typically responsible for handling more than 30 studies with multiple studies running concurrently.
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Manager Of Information Department, Chief EditorBeijing China Medicom Ltd. / Beijing Drugnet Ltd. Jun 2002 - May 2005Beijing• Responsible for the reviewing, integration, management and analysis of the bidding pharmaceutical data.• Maintenance web station database and business information. • Responsible for the edit, design, print and publish of
journal. • Responsible for website maintenance for bidding business. -
Manager Of Information Department, Chief EditorNational Institute Of Hospital Administration / Pacific Medicine Information Ltd. Feb 1999 - May 2002Beijing• Responsible for maintain ‘Chinese Hospital Information database’, such as study setup, database design, data entry, data management, data analysis, etc. • Responsible for the edit, design, print and publish of
journal. • Responsible for the edit, translation, print and publish of books about hospital management. • Responsible for website maintenance for hospital information and hospital management. -
Associate Director Of Dust Monitoring And Research CenterInstitute Of Occupational Medicine Of Coal Industry Sep 1996 - Jan 1999Beijing• Responsible for data management and data statistics analysis for more than 15 occupational epidemiology studies.• Perform statistical analysis and write statistical study reports; • Design questionnaires and conduct investigations. Perform SAS programming, data clean and data validation process, etc. • Responsible for research and development of dust observation system.
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Quality Control InspectorHunan Huiyanfeng Winery Factory Aug 1989 - Aug 1993Hunan• Responsible for the quality control, including for raw material, all kind of products and product procedure. • Ensure workers and bartenders following the standard operation flow.
王秀兰 Education Details
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Chinese Management Science Research Institute(Beijing Yingxiangli )P-Mba -
Tongji Medical University(华中科技大学同济医学院)Occupational Health And Diseases(劳动卫生与职业病学) -
Hunan College Of Environmental BiotechnologyMajor In Public Health
Frequently Asked Questions about 王秀兰
What is 王秀兰's role at the current company?
王秀兰's current role is 制药 - 在职者.
What schools did 王秀兰 attend?
王秀兰 attended Chinese Management Science Research Institute(Beijing Yingxiangli ), Tongji Medical University(华中科技大学同济医学院), Hunan College Of Environmental Biotechnology.
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