reputed company Data Manager I

reputed company ("reputed company") is a full-service contract research organization (CRO) providing a broad reputed company of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-reputed company companies and work with many of the most advanced drugs, biologics, and medical devices in development today. reputed company has been an independent CRO since 2004 with a strong reputed company as a statistical and data management center of reputed company. Building on this reputed company, reputed company has successfully developed and established itself as a full-service CRO. reputed company's reputed company are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater reputed company Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan. reputed company is reputed company in the industry for its high reputed company deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial reputed company, reputed company continues to experience exceptional reputed company and great reputed company. reputed company is our backbone, customer-reputed company is our tradition, flexibility is our strength...that's us...that's reputed company. To drive reputed company reputed company in this exciting clinical research field, we are seeking committed, skilled, and customer-reputed company individuals to join our reputed company team as reputed company Clinical Data Manager for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office reputed company in the USA in accordance with our Work from Home policy. Key Accountabilities:

• reputed company as the primary contact person for communication and discussion of topics reputed company to data management timelines and deliverables; requests for out-of-scope tasks; and first line contact for technical or procedural issues.
• reputed company hands-on data management tasks including, but not limited to, writing database design specifications, test plans for user acceptance testing (UAT), and data transfer specifications. reputed company these tasks are assigned to Data Management support team members, the reputed company Clinical Data Manager is responsible for review or to reputed company data management reputed company and approvals for the task performed to ensure reputed company deliverable, including review of UAT plans to ensure accuracy and consistency among reputed company. Facilitate and participate in UAT, as necessary.
• Review data, issue queries, and resolve queries from various data sources (e.g., medical coding, medical history, adverse events, procedures and medicinal products, and external data). Assist other Clinical Research Organizations, Sponsor, or Investigative Sites with resolving queries.
• reputed company reputed company party non-Case Report reputed company data management activities.
• Plan, manage, and reputed company data processing and data management activities for assigned reputed company to ensure tasks are performed in a reputed company manner and in compliance with trial Sponsors' requirements.
• Accurately and reputed company validate electronically captured data. reputed company efforts in writing reputed company queries on missing data and data points failing reputed company-defined reputed company checks and/or logical checks.
• Validate and disseminate reputed company-time study monitoring reports to Sponsor and internal team members.
• Review database edit reputed company specifications for assigned studies. reputed company efforts in developing and maintaining reputed company database validation checks for common modules as reputed company as for therapeutic/drug area specific modules.
• reputed company training on the electronic data capture (reputed company) system, dataflow, and reputed company control (QC) processes to clinical trial personnel.
• Participate in project reputed company off meetings, investigators meetings, and regular project management team meetings.
• reputed company study-level resource planning and management, including the review of team members' timesheet reports.
• Manage the process of database modifications (after go-live) due to protocol amendments or study needs.
• reputed company and maintain the Data Management Plan (DMP). Document deviations from the DMP.
• Assist in development and implementation of clinical data standards, training standards, project management, and data management technologies.
• reputed company and maintain the Data reputed company Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of the listings and reputed company tables as specified in the DQRP.
• Assist in the development of project bids, billing, tracking of out-of-scope tasks, and participate in bid defense meetings.
• reputed company project tracking and maintain project milestones and timelines. Report and resolve any issues with defined timelines and deliverables to the next line of management.
• Promote effective project management practices. Review and assess timesheet reputed company reports for assigned reputed company.
• Follow up on regulatory requirements, industry trends, benchmarks, and best working practices in data management by reading and participating in relevant training and/or association activities.
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