[Remote] Senior Clinical Database Designer I

Note: The job is a remote job and is open to candidates in USA. Everest Clinical Research is a full-service, global, contract research organization providing clinical research services to pharmaceutical, biotechnology, and medical device industries. The Senior Clinical Database Designer will develop and enhance database design capabilities, assist in managing the clinical database design process, and ensure compliance with regulatory requirements.ResponsibilitiesDevelop new features and functionality within 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 capabilitiesAssist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance processReview 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 practicesFollow 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 activitiesDesign and review case report forms (CRFs/eCRFs) and setup electronic data capture (EDC) systems for clinical trialsAuthor and review the Data Validation Specifications for assigned projectsDevelop and review User Acceptance Test (UAT) plans for clinical databases designed by other designers. Coordinate and oversee the UAT process for clinical databasesDesign and review patient Case Report Forms and database schema. Test data capture/entry screens through UATParticipate in EDC vendor’s technical learning and exchange meetings as well as other internal and external training meetingsParticipate in trial Investigators Meetings and provide user training to CRAs on how to use EDC systems, and on Dataflow and Quality Control ProcessesContribute to the development and maintenance of the company’s database design procedural documents, work instructions, checklists and templates for all EDC systemsProvide input to all data management procedural documentsPlan, manage, control and perform data processing activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial sponsors’ requirementsReview the Data Management Plan (DMP) for assigned projectsReview data, issue and resolve queries. Assist the Lead Data Manager, sponsor or Investigative Site with resolving queriesAssist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal productsCooperate with and assist the Quality Assurance Department with quality control audits on assigned databases. Validate and disseminate real-time study monitoring reports to sponsor and internal team membersDefine and monitor clinical trial data flow and quality control processes in accordance to corporate SOPs, Good Working Practices, and unit guidelinesAccurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checksParticipate in and contributes to Clinical Data Management initiativesDevelop and test SAS codes for clinical trial database logical checks and study specific monitoring reportsSkillsB.Sc. in Biological Sciences or Computer ScienceFive years' related experienceTwo to three years developing Inform and/or Medidata Rave (or similar) clinical data bases. Previous Clinical Data Management experience in both paper based and electronic data capture systemsMust communicate effectively, orally and in writing, with personnel on all professional and administrative levelsProven leadership and interpersonal skills in complex team situationsExcellent presentation skills and the ability to build relationships with both internal and external clientsMust be well organized and able to work independently and manage multiple projects/tasks appropriatelyDemonstrated ability to effectively organize and integrate the activities of information processing personnelBenefitsMedical, dental, and vision coverageLife & AD&D insuranceShort- and long-term disabilityTuition reimbursementFitness reimbursementEmployee assistance program (EAP)A 401(k) retirementGenerous paid time off and sick leaveThe opportunity to earn a performance based bonusCompany OverviewEverest Clinical Research is a firm which conducts clinical research by contract for firms across the globe in fields It was founded in 2004, and is headquartered in Markham, Ontario, CAN, with a workforce of 501-1000 employees. Its website is https://www.ecrscorp.com/.Company H1B SponsorshipEverest Clinical Research has a track record of offering H1B sponsorships, with 1 in 2026, 4 in 2025, 4 in 2024, 4 in 2023, 3 in 2022, 1 in 2021. Please note that this does not guarantee sponsorship for this specific role.