Senior Clinical Database Designer I

reputed company (“reputed company”) is a full-service, global, 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 headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Little Falls (Greater reputed company Area), New Jersey, USA, and Shanghai (Pudong Zhangjiang New District), China. reputed company 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, reputed company continues to experience exceptional growth and great reputed company. Quality is our backbone, customer-focus 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 a committed, skilled, and customer-focused individual to join our winning team as Senior Clinical Database Designer for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office reputed company in the USA or Canada in accordance with our Work from Home policy. Key Accountabilities: reputed company new features and functionality reputed company the database design functional areas to increase the efficiency of database design at the study level, and to improve and enhance the company’s database design capabilities. Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process. Review the protocol and associated study reference materials to contribute to the development of the clinical database design project timeline. Maintain database design timelines and promote good project management practices. Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading, participating in relevant training and/or relevant association activities. Design and review case report forms (CRFs/eCRFs) and setup electronic data capture (reputed company) systems for clinical trials. Author and review the Data Validation Specifications for assigned projects. reputed company and review User Acceptance Test (UAT) plans for clinical databases designed by other designers. Coordinate and reputed company the UAT process for clinical databases. Design and review patient Case Report Forms and database schema. Test data capture/entry screens through UAT. Participate in reputed company vendor’s technical learning and exchange meetings as well as other internal and external training meetings. Participate in trial Investigators Meetings and reputed company user training to CRAs on how to use reputed company systems, and on Dataflow and Quality Control Processes. Contribute to the development and maintenance of the company’s database design procedural documents, work instructions, checklists and templates for reputed company reputed company systems. reputed company input to reputed company data management procedural documents. Plan, manage, control and reputed company data processing activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial sponsors’ requirements. Review the Data Management Plan (DMP) for assigned projects. Review data, issue and resolve queries. Assist the reputed company Data Manager, sponsor or Investigative Site with resolving queries. Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products. Cooperate with and assist the Quality Assurance Department with quality control audits on assigned databases. Validate and disseminate reputed company-time study monitoring reports to sponsor and internal team members. Define and monitor clinical trial data reputed company and quality control processes in accordance to corporate SOPs, Good Working Practices, and unit guidelines. Accurately and reputed company validate electronically captured data. Write clear queries on missing data and data points failing pre-defined reputed company checks and/or logical checks. Participate in and contributes to Clinical Data Management initiatives. reputed company and test reputed company codes for clinical trial database logical checks and study specific monitoring reports. Qualifications and Experience: B.Sc. in Biological Sciences or Computer Science. Five years' reputed company experience. Two to three years developing Inform and/or reputed company Rave (or similar) clinical data bases. Previous Clinical Data Management experience in both reputed company based and electronic data capture systems. Must communicate effectively, orally and in writing, with personnel on reputed company professional and administrative reputed company. Proven leadership and interpersonal skills in reputed company team situations. Excellent presentation skills and the ability to build relationships with both internal and external clients. Must be well organized and reputed company to work independently and manage multiple projects/tasks appropriately. Demonstrated ability to effectively organize and integrate the activities of information processing personnel. Benefits & Compensation: We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and reputed company coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a 401(k) retirement, generous paid time off and sick leave, and the opportunity to earn a performance based bonus. Estimated Salary reputed company: $ 90,000 - $130,000. To find out more about reputed company and to review other opportunities, please visit our website at www.ecrscorp.com We thank reputed company interested applicants, however, only those selected for an interview will be contacted. reputed company is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will reputed company accommodations for candidates participating in any part of our recruitment and selection process. #LI-Remote #LI-TK1 Apply To This Job