Clinical Data Manager

Everest Clinical Research (“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-known 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 New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, 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 continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Clinical Data Managers for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy. Key Accountabilities: Plan, manage, control, and perform data processing and management activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial Sponsors’ requirements. Lead assigned data processing and management projects by applying project management skills, data processing, and management techniques. Manage timelines and coordinate activities for assigned projects. Specify database validation checks for assigned studies. Lead efforts in developing and maintaining standard database validation checks for common modules as well as for therapeutic/drug area specific modules. Define and monitor clinical trial dataflow and quality control (QC) processes in accordance to corporate Standard Operating Procedures (SOPs), Good Working Practices, and unit guidelines. Perform clinical trial site monitors’ training on dataflow and QC processes. Design and review patient Case Report Forms (CRFs) and database schema. Test data capture/entry screens. Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks. Lead efforts in building a standard query library for common database modules, as well as for therapeutic/drug area specific modules. Perform QC procedures on assigned database during the trial and additional database closure checks at the end of the study. Train and supervise Data Entry personnel and junior data management personnel on study procedures, study specific handling, and management of trial data. Validate and distribute study progress status reports to internal and external study team members. Assist in resolving data coding discrepancies resulting from the coding of medical events, treatment procedures, and medications. Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving clinical trial data and study documentation. Cooperate with and assist, when required, data management quality assurance (QA) personnel in performing QA procedures on trial CRFs, database schema, and databases for assigned studies. Qualifications and Experience: A Bachelors’ degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields with at least 2 years experience in clinical trial data capture and management, or a Master’s or Ph.D degree in these fields with at least 1 year relevant experience. In-depth understanding of clinical trial data management concepts, processes and procedures, relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions and standards. Strong leadership in clinical data management activities and a desire to excel in leading data management projects.