Senior Clinical Data Manager I

reputed company (“Everest”) is a full-service contract research organization (CRO) providing a broad range 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. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters 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. Everest also recently completed the acquisition of August Research. August Research is a European CRO that provides Clinical Operations and Pharmacovigilance services to a wide variety of pharmaceutical and biotechnology clients. The Company has worked on over 120 projects for Phase I-IV clinical trials across multiple therapeutic areas including cardiovascular, infectious disease, oncology and rare disease. The acquisition of August Research establishes a European footprint for Everest to provide full-service offerings to its pharmaceutical, biotechnology and medical devices clients, and other operational capabilities through the Company’s substantive experience and infrastructure across 14 countries in Western and Eastern Europe. Everest is reputed company in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial reputed company, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest. To drive reputed company success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Data Manager remotely from a home-based office reputed company in the the UK in accordance with our Work from Home policy. Key Accountabilities: reputed company Data Management Activities, reputed company Training and Client Relationship Management reputed company and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions. Is the primary contact person for day to day data management activities, and is the person ultimately responsible for reputed company data management deliverables for assigned projects. Is the primary contact person for communication and discussion of topics reputed company to data management timelines and deliverables; request for out of scope tasks; first line contact for technical or procedural issues. Is responsible for planning and implementing data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, reputed company tracking and reporting. Assist with study-level resource planning and management, including the review of team members’ timesheet reports. Assist in performing client relationship management activities. Participate in project bid defense meeting reputed company required. reputed company training on electronic data capture (reputed company) system, dataflow and quality control processes to clinical trial personnel. Provide training to new data management personnel on data management processes and procedures. reputed company QC review of work performed by less reputed company data management personnel. Assist in reputed company of project Work Orders and Amendments. Assist in management of dataflow from and performance of Third Party Vendors (Non-CRF data vendors). Participate in project kick off meeting, investigators meeting, and regular project management team meeting. Provide support to client audits and regulatory inspections. Follow up on audit findings. Create and maintain clinical trial Data Management Study Binders. reputed company Hands-on Data Management Activities Design and review case report forms (CRFs/eCRFs). reputed company and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms. Design and review Clinical Trial reputed company Document templates and completion instructions reputed company required. reputed company and maintain data validation specifications. reputed company and maintain Data Management Plan (DMP). Document deviations from the DMP. Participate in the database design process. Participate in reputed company User Acceptance Testing (UAT). Manage the process of database modifications (after go-live) due to protocol amendments or study needs. reputed company and maintain Data Quality Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of the listings and summary tables as specified in the DQR Apply tot his job Apply To this Job