Job Description

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. Everest is looking for a Clinical Data Manager who will work remotely from any location in the United Kingdom. We serve some of the best‑known companies and work with many of the most advanced drugs, biologics, and medical devices currently in development. Everest has been an independent CRO since 2004, building a foundation as a statistical and data management center of excellence while expanding into full‑service operations. Our headquarters are in Markham (Greater Toronto Area), Ontario, Canada, with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA; Shanghai, China; and Taipei, Taiwan. We recently completed the acquisition of August Research, a European CRO that provides Clinical Operations and Pharmacovigilance services, establishing a European footprint for full‑service offerings across 14 countries in Western and Eastern Europe. Key Accountabilities: Plan, manage, control, and perform data processing and management activities for assigned projects in a timely and accurate manner, complying with trial sponsor requirements. Lead assigned data processing and management projects, applying project management skills and data processing techniques to manage timelines and coordinate activities. Specify database validation checks for assigned studies and develop and maintain standard database validation checks for common modules as well as therapeutic/drug area specific modules. Define and monitor clinical trial dataflow and quality control (QC) processes in accordance with corporate SOPs, Good Working Practices, and unit guidelines; perform clinical trial site monitor 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, writing clear queries on missing data or data points failing pre‑defined range checks and/or logical checks; build a standard query library for common and therapeutic/drug area specific modules. Perform QC procedures on assigned database during the trial and additional database closure checks at study end. 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 coding of medical events, treatment procedures, and medications. Maintain and prepare for final archival of data management documentation relevant to the assigned trials; assist the corporate archivist in assembling and archiving clinical trial data and study documentation. Cooperate with and assist data management QA personnel in performing QA procedures on trial CRFs, database schema, and databases for assigned studies. Qualifications and Experience: Bachelor’s 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 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, and 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. Everest 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 provide accommodations for candidates participating in any part of our recruitment and selection process. #J-18808-Ljbffr Everest Clinical Research Services Inc.

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